Journal of Refractive Surgery

Original Article Supplemental Data

Clinical Effectiveness of Laser-Induced Increased Depth of Field for the Simultaneous Correction of Hyperopia and Presbyopia

Nesrine Rahmania, MD, MSc; Imène Salah, PhD; Radhika Rampat, MD; Damien Gatinel, MD, PhD

Abstract

PURPOSE:

To evaluate the visual outcomes of patients with presbyopic hyperopia, comparing the current standard of monovision treatment with a novel bilateral presbyopic LASIK (Custom-Q mode) technique.

METHODS:

This prospective comparative study of consecutive eligible patients with presbyopic hyperopia undergoing a bilateral presbyopic laser in situ keratomileusis technique was conducted between January 2018 and February 2019. After contact lens–simulated monovision measurements were obtained, the non-dominant eyes had a negative aspheric ablation profile planned using the Custom-Q nomogram (Alcon Laboratories, Inc). The dominant eye was operated on with a positive aspheric ablation profile. Visual acuity testing, refraction, corneal asphericity (▵Q), higher order aberrations, and a satisfaction questionnaire (National Eye Institute Refractive Error Quality of Life) were evaluated after the monovision trial and postoperatively.

RESULTS:

Twenty-eight patients, with a mean age of 56.03 ± 4.31 years, were included in the study. At 6 months, 100% of patients achieved 20/20 or better binocular uncorrected distance visual acuity (UDVA) versus 57% in the monovision group, 100% of patients achieved 20/25 or better binocular uncorrected intermediate visual acuity versus 32% in the monovision group, and 92.86% of patients achieved 20/25 or better binocular uncorrected near visual acuity (UNVA) in both groups. In contact lens monovision simulation, no patient reached a UDVA of 20/50 or better, with only 3.6% having a UNVA of 20/40 or better. The questionnaire demonstrated high patient satisfaction.

CONCLUSIONS:

The outcomes confirm the superiority of increased depth of focus using negative spherical aberration modulation in the non-dominant eye compared with contact lens monovision. They also demonstrate the effectiveness of positive spherical aberration induction to improve intermediate and near vision in the dominant eye.

[J Refract Surg. 2021;37(1):16–24.]

Abstract

PURPOSE:

To evaluate the visual outcomes of patients with presbyopic hyperopia, comparing the current standard of monovision treatment with a novel bilateral presbyopic LASIK (Custom-Q mode) technique.

METHODS:

This prospective comparative study of consecutive eligible patients with presbyopic hyperopia undergoing a bilateral presbyopic laser in situ keratomileusis technique was conducted between January 2018 and February 2019. After contact lens–simulated monovision measurements were obtained, the non-dominant eyes had a negative aspheric ablation profile planned using the Custom-Q nomogram (Alcon Laboratories, Inc). The dominant eye was operated on with a positive aspheric ablation profile. Visual acuity testing, refraction, corneal asphericity (▵Q), higher order aberrations, and a satisfaction questionnaire (National Eye Institute Refractive Error Quality of Life) were evaluated after the monovision trial and postoperatively.

RESULTS:

Twenty-eight patients, with a mean age of 56.03 ± 4.31 years, were included in the study. At 6 months, 100% of patients achieved 20/20 or better binocular uncorrected distance visual acuity (UDVA) versus 57% in the monovision group, 100% of patients achieved 20/25 or better binocular uncorrected intermediate visual acuity versus 32% in the monovision group, and 92.86% of patients achieved 20/25 or better binocular uncorrected near visual acuity (UNVA) in both groups. In contact lens monovision simulation, no patient reached a UDVA of 20/50 or better, with only 3.6% having a UNVA of 20/40 or better. The questionnaire demonstrated high patient satisfaction.

CONCLUSIONS:

The outcomes confirm the superiority of increased depth of focus using negative spherical aberration modulation in the non-dominant eye compared with contact lens monovision. They also demonstrate the effectiveness of positive spherical aberration induction to improve intermediate and near vision in the dominant eye.

[J Refract Surg. 2021;37(1):16–24.]

Presbyopia has become a significant physiological change that patients want to address, with the increasing pressure to read or work on various electronic devices at a near or intermediate distance.1–3 Surgical correction of presbyopia has become a new focus point, but it still has its challenges and compromises, with no current consensus reached.4–13 There are a range of approaches to the corneal correction of presbyopia with laser in situ keratomileusis (LASIK). Leray et al14 showed interest in the modulation of asphericity by increasing the depth of field without compromising distance vision using the principle of micro-monovision. However, they concluded that an optimal aspheric value for each eye needed to be defined.

Modulation of spherical aberration Z40 to increase the depth of field is a recent and attractive approach for the correction of presbyopia and hyperopia, with creation of a power gradient from the center to the peripheral cornea.15 Increasing the corneal prolateness and inducing negative spherical aberration in the non-dominant eye improves distance vision because of a reduction of corneal curvature leading to emmetropization of the corneal periphery. This gradual reduction of myopia toward the edge of the pupil avoids unnecessarily diminishing the uncorrected distance visual acuity (UDVA). The theoretical influence of change in asphericity was studied and calculated by Gatinel et al16,17 in 2014 and led to the development of a correction nomogram aimed at modulating the corneal spherical coefficient (C40) by an amount of ΔC40 = −0.4 µm for a 6-mm pupil diameter. We previously reported the encouraging clinical outcomes of this combined presbyopic hyperopic LASIK surgery technique in 2016, with a multifocal method aimed at corneal asphericity modulation in the non-dominant eye.18 There are other theoretical modalities to increase the depth of focus of the presbyopic eye: some multifocal lens designs and presbyopic LASIK strategies increase positive spherical aberration by increasing the optical power of the eye in a concentric peripheral pupil area while leaving the center corrected for emmetropia.16,17 Hence, a presbyopic LASIK profile can be designed so that the dominant eye can achieve emmetropia centrally with induction of positive spherical aberration and, therefore, a slight myopic defocus toward the pupil periphery to improve intermediate and near vision. In such an approach, the induction of a paraxial emmetropic correction should preserve the maximal contrast visual distance acuity.

The main objective of this study was to compare the visual performance of hyperopic, presbyopic patients who had LASIK using bilateral but opposing aspheric (Custom-Q mode) photoablation profiles, with simulated conventional monovision (soft contact lens trial) before surgery.

Patients and Methods

A prospective, comparative, superiority study was conducted at the Institute of Laser Vision, Noémie de Rothschild, Paris, France. Data were collected from January 2018 to February 2019 after the power of the study was calculated. The study was approved by the ethics committee, followed the tenets of the Declaration of Helsinki, and informed signed consent was obtained from patients before inclusion in the study. The inclusion criteria were consecutive, farsighted presbyopic patients aged at least 43 years old and eligible for an optimized surgical correction of both distance and near vision. Hyperopia was defined as wearing a spectacle correction of +0.50 diopters (D) or greater, giving a visual acuity of 20/20. Presbyopia was defined as the need for a reading add of at least +1.25 D to attain a near visual acuity of 20/20 with a stable refraction for at least 6 months. The pupil size must exceed 1.5 mm when measured with the Topolyzer Allegro Vario (Alcon Laboratories, Inc).

The criteria for exclusion were patients with a history of refractive surgery or corneal surgery, patients with greater than 4.00 D of hyperopia, corneal astigmatism greater than 1.75 D, a corrected distance visual acuity of worse than 20/20, or dry eye syndrome (any superficial punctate keratitis or tear break-up time of less than 2 seconds), a structural abnormality of the cornea (keratoconus, corneal opacities, or erosions), residual corneal thickness less than 300 µm, uncontrolled diabetes, cataracts, amblyopia, glaucoma, or any retinal disease.

Preoperative Evaluation and Monovision Simulation

All patients had a comprehensive ophthalmic examination including manifest and cycloplegic refractions, non-contact intraocular pressure evaluation, slit-lamp examination of the anterior segment, and dilated funduscopy. Preoperative examination included keratometry, topography analysis with Orbscan II (Bausch & Lomb), wavefront aberrometry on a 5-mm pupillary diameter, and pupillometry analysis with OPD-Scan III (Nidek, Inc). Ocular dominance was determined using the pinhole test and the lens fogging technique.19 Corneal asphericity and corneal wavefront root mean square (RMS) coefficients for primary and secondary spherical aberration (c40, c60), coma (c3±1), and total higher order aberrations (HOAs) were assessed before and at 1, 3, and 6 months after surgery (5-mm zone). Lens density was analyzed using double-pass aberrometry (OQAS instrument; Visiometrics). UDVA, uncorrected intermediate visual acuity (UIVA), and uncorrected near visual acuity (UNVA) were recorded preoperatively, with contact lenses simulating monovision, and then after surgery.

Each patient was fitted with soft monofocal hydrophilic contact lenses (Dailies Total One or Air Optix hydraglyde; Alcon Laboratories, Inc) to assess monovision tolerance prior to surgery, and then monocular and binocular visual acuities were measured. A slight residual hyperopia of +0.50 D was targeted in the dominant eye (to avoid the likelihood of a myopic result that is not tolerated by patients with lifelong hyperopia), whereas lens power was calculated for a target refraction of +2.50 D in the non-dominant eye. Patients wore these lenses for at least 30 minutes prior to acuity and dilation.

Principles of Aspheric Laser Correction

In classic monovision, the dominant eye is corrected to achieve satisfactory UDVA, whereas the non-dominant eye is corrected to see well at near without correction. Using the proposed nomogram, in the non-dominant eye, some level of usefulness is achieved by inducing a myopic defocus within the paraxial zone (center) and altering the ablation profile within the paracentral zone (periphery) using a target change in corneal asphericity (ΔQ). The refraction of the non-dominant eye, still dominated by the paraxial defocus, incurs a reduction of myopic defocus in the paracentral zone when a more prolate asphericity is induced. This defocus gradient from the center to the edge of the pupil corresponds to the induction of negative spherical aberration (Figure 1). Related computations were addressed in previous studies,16 which found an optimal target change of corneal asphericity of ΔQ = −0.6 regardless of the spherical correction and value of the initial corneal asphericity. In our study, emmetropia or a slight hyperopia was the central target in the dominant eye, as in monovision settings, but a slight positive asphericity change of ΔQ = +0.2 was targeted to enhance the UIVA/UNVA and limit the loss of stereoacuity. The magnitude of the change in asphericity was determined using both empirical and theoretical findings (unpublished data).

Changes in binocular (A) distance, (B) intermediate, and (C) near visual acuity following surgical treatment at 1 (in red), 3 (in green), and 6 (in purple) months postoperatively compared with contact lens wear (CL) simulating monovision preoperatively (in blue).

Figure 1.

Changes in binocular (A) distance, (B) intermediate, and (C) near visual acuity following surgical treatment at 1 (in red), 3 (in green), and 6 (in purple) months postoperatively compared with contact lens wear (CL) simulating monovision preoperatively (in blue).

To evaluate the results of such an approach, the results of this nomogram were compared with monovision in the same individuals. This was achieved preoperatively by simulating classic monovision with contact lenses. Patient satisfaction was assessed using the National Eye Institute Refractive Error Quality of Life (NEI RQL-42) questionnaire. The expected UDVA for the non-dominant eye is 20/125 with the monovision contact lens test according to the highest expectations with Swaine's (empirical inverse scale) rule,20 and a safe estimate of 20/60 with the planned laser surgery, according to clinical practice and the data from the study by Courtin et al18 (1-month UDVA for non-dominant eye was 20/40).

Surgical Procedure and Treatment Planning

Bilateral LASIK was performed with the WaveLight Refractive Suite platform (Alcon Laboratories, Inc) by the same surgeon (DG). The flap creation was performed with the WaveLight FS200 femtosecond laser, using standard treatment for a diameter of 9.6 mm and a thickness of 140 µm. Preoperative Q Values (Q1) were measured on the same day as the bilateral procedure, using the WaveLight Topolyzer Vario instrument (Alcon Laboratories, Inc).

Photoablation was performed with the WaveLight EX500 excimer laser using the Custom-Q photoablation mode using iris recognition for cyclotorsion compensation and custom centration (75% distance from pupil center to corneal vertex) on a 6.5-mm optic zone. For the dominant eye, distance vision was corrected with a target refraction of +0.50 D. We aimed at reducing corneal prolateness by adding 0.2 to the measured asphericity (Q1), such as target asphericity on the dominant eye was Q2 = Q1 + 0.2. In the non-dominant eye, the target refraction was −2.50 D, and the more prolate target asphericity was Q2' = Q1 − 0.6.

Postoperative Evaluation

Data were collected 1, 3, and 6 months postoperatively as defined in Table A (available in the online version of this article). Re-treatment was performed if the patient was unsatisfied with the result after 6 months of follow-up. Patients received information about the risks and benefits of LASIK re-treatment.

Study Visit Schedulea

Table A:

Study Visit Schedule

Statistical Analysis

All data collection was conducted using Microsoft Excel 2011 database (Microsoft Corporation). Analyses of data were performed using SPSS software (IBM Corporation). Values were obtained by the same investigator (NR) preoperatively and at 1, 3, and 6 months postoperatively. The values were compared using a paired t test when the values followed a normal distribution (Shapiro-Wilk test with P < .05). Bivariate correlations were calculated with the Pearson's correlation coefficient where each parameter followed a normal distribution. Data were expressed as mean ± standard deviation. A P value of less than .05 was considered statistically significant.

Results

Twenty-eight patients were included in the study (23 women and 5 men). The mean age of enrolled patients was 56.03 ± 4.31 years (range: 49 to 66 years). The mean preoperative spherical equivalents were +1.66 ± 0.92 D (range: 0.25 to 4.00 D) and +1.44 ± 0.91 D (range: +0.25 to +3.75 D; P = .061) in the non-dominant and dominant eyes, respectively.

Efficacy

All 28 patients completed their follow-up through 6 months. At 6 months of follow-up, 100% of patients achieved 20/20 or better binocular UDVA, 100% of patients achieved 20/25 or better binocular UIVA, and 92.86% of patients achieved 20/25 or better binocular UNVA (Figure 1). Looking at the visual function of the non-dominant eye at 6 months postoperatively, 60.71% patients achieved 20/32 or better UDVA, 89.28% patients achieved 20/32 or better UIVA, and 96.42% patients achieved 20/32 or better UNVA (Figure 2). All patients achieved 20/20 or better UDVA, 89.29% achieved 20/25 or better UIVA, and 60.71% achieved 20/40 or better UNVA in the non-dominant eye at 6 months postoperatively (Figure 3).

Changes in (A) distance, (B) intermediate, and (C) near visual acuity in the non-dominant eye following surgical treatment at 1 (in red), 3 (in green), and 6 (in purple) months postoperatively compared with contact lens wear (CL) simulating monovision preoperatively (in blue).

Figure 2.

Changes in (A) distance, (B) intermediate, and (C) near visual acuity in the non-dominant eye following surgical treatment at 1 (in red), 3 (in green), and 6 (in purple) months postoperatively compared with contact lens wear (CL) simulating monovision preoperatively (in blue).

Changes in distance (A) intermediate (B) and near (C) visual acuity in the dominant eye following surgical treatment at 1 (in red), 3 (in green), and 6 (in purple) months postoperatively compared with contact lens wear (CL) simulating monovision preoperatively (in blue).

Figure 3.

Changes in distance (A) intermediate (B) and near (C) visual acuity in the dominant eye following surgical treatment at 1 (in red), 3 (in green), and 6 (in purple) months postoperatively compared with contact lens wear (CL) simulating monovision preoperatively (in blue).

Pearson's correlation test between UDVA improvement in the non-dominant eye at 6 months and maximum pupillary diameter revealed statistical significance (r = 0.385; P = .043). No statistical difference was found between UDVA in non-dominant eyes and minimal pupillary diameter.

Corneal Spherical Aberration Coefficient C(4,0)

Corneal spherical aberration variation was statistically different between non-dominant and dominant eyes at months 1, 3, and 6 (Figure 4A). In the non-dominant eyes, the postoperative values were lower than in the dominant eyes where the values were positive, due to central steepening in the non-dominant eyes and central flattening in the dominant eyes.

Changes in (A) corneal spherical aberration coefficient values and (B) corneal asphericity (Q) in non-dominant and dominant eyes. RMS = root mean square

Figure 4.

Changes in (A) corneal spherical aberration coefficient values and (B) corneal asphericity (Q) in non-dominant and dominant eyes. RMS = root mean square

Corneal Asphericity (Q factor)

As expected, compared to preoperative measurements, corneal asphericity, which was not statistically different preoperatively between non-dominant and dominant eyes, respectively, was more prolate at 1, 3, and 6 months after surgery (Figure 4B). A mild correlation (R2 = 0.41) between the actual and the expected Q-factor was highlighted using a simple linear regression in both non-dominant and dominant eyes (Figure A, available in the online version of this article).

Relationship between expected and achieved corneal asphericity (Q) factor 6 months postoperatively in non-dominant eyes.

Figure A.

Relationship between expected and achieved corneal asphericity (Q) factor 6 months postoperatively in non-dominant eyes.

Safety

At 6 months postoperatively, there was no loss of vision, infection, or inflammation noted in any of the patients enrolled in the study.

Accuracy

Spherical equivalents were statistically different at 3 and 6 months between non-dominant and dominant eyes. Initial anisometropia in contact lens–matched planned presbyopic LASIK values and were statistically different at 6 months postoperatively. Table 1 summarizes the corneal RMS evolution rates regarding spherical aberration, coma, and HOAs preoperatively and postoperatively.

Corneal Total RMS Evolutiona

Table 1:

Corneal Total RMS Evolution

Stability/Re-treatment

Only 2 patients (7.14%) needed re-treatment after 6 months of follow-up. Emmetropia was achieved in both patients after re-treatment.

NEI RQL-42 Questionnaire

Patient satisfaction was assessed using the NEI RQL-42 questionnaire. Five parameters were assessed, the score being better when closer to 100. Clarity of vision, symptoms, satisfaction, appearance, and expectations were statistically better 6 months postoperatively compared to the values with contact lenses simulating monovision (Figure B, available in the online version of this article). Side effects included halos in mesopic vision and dry eye complaints.

National Eye Institute Refractive Error Quality of Life (NEI RQL-42) questionnaire scores before surgery with contact lenses (CL) and 6 months postoperatively.

Figure B.

National Eye Institute Refractive Error Quality of Life (NEI RQL-42) questionnaire scores before surgery with contact lenses (CL) and 6 months postoperatively.

Discussion

Our results support the validity of the nomogram by Gatinel et al,16 based on an established theoretical model allowing the simultaneous correction of presbyopia and hyperopia using Presbyopic LASIK. This mathematical modeling concluded that for the non-dominant eyes, a variation of −0.4 µm of the coefficient c(4, 0) (Δc(4.0) = − 0.4 µm on a 6-mm pupil) required a variation of the Q factor between −0.6 and −0.7. This change is theoretically robust to the value of the initial keratometry, the initial asphericity, or delivered hyperopic correction. Furthermore, Amigo et al21 also showed that the induction of a more negative spherical corneal aberration than −0.4 µm does not increase the depth of field. Courtin et al18 demonstrated the efficacy and safety of such an aspherical correction profile on the non-dominant eye in a retrospective study of 49 patients. However, the study design did not provide comparisons with single monovision and the asphericity had not been modified in the dominant eyes.

The correction in the dominant eyes by presbyopic LASIK techniques found in the literature essentially consists of inducing peripheral steepening or applying a monofocal correction in distance vision without modifying the asphericity. To our knowledge, this is the first study to explore the surgical benefit of flattening the cornea in the dominant eyes and comparing the results of surgery versus contact lens–simulated monovision.

Asphericity Modulation Benefit in the Non-Dominant Eyes

The change in asphericity (Q) at 6 months was significantly different between the dominant eyes and the non-dominant eyes. The achieved asphericity in the non-dominant eyes (−0.44 ± 0.24) was nevertheless different than the expected values of −0.6 to −0.7, whereas the achieved asphericity in the dominant eyes (0.05 ± 0.4) was relatively close to expected values (approximately 0). Alarcón et al22 showed that the F-CAT algorithm did not result in the intended asphericity and neither did other studies using the F-CAT algorithm.23,24 The variation in spherical aberration c(4,0) obtained in the non-dominant eyes (−0.07 ± 0.15 µm) was also different than the expected value of −0.4 µm. This could be explained by the measurements of the RMS values on a fixed 5-mm size pupil and not 6 mm, as was described in the initial theoretical work.16 We performed our measurements on a diameter of 5 mm because most eyes had a pupil diameter measured at less than 6 mm in mesopic conditions. The RMS rate of spherical aberration varies with pupil diameter at power 4, and theoretically decreases by 2 for a diameter reduction of 6 to 5 mm. This partly explains the difference between the variation in spherical aberration referred to by modulation of corneal asphericity and that measured postoperatively.

Courtin et al18 reported a variation of spherical aberration Δc(4.0) = − 0.49 ± 23 µm, which is closer to the expected value of −0.4 µm, as expected from measurements performed on a 6-mm pupil diameter. These disparities can be explained by the differences in the target refraction in the non-dominant eyes. Wang et al24 evaluated the benefit of a personalized Q nomogram (Q from −0.6 to −0.8), and found an average final spherical aberration at 12 months in 69 patients of −0.29 ± 0.20 µm on a 6-mm pupil diameter. Our values are close to those found by Courtin et al.18 In the study by Leray et al,14 an increase in the depth of field was noted in the non-dominant eyes if the corneal spherical aberration c(4.0) was less than 0.075 µm on a pupil of 4.5 mm. This is confirmed in our study, where the corneal spherical aberration of the non-dominant eyes, although measured on a 5-mm pupil, is equal to 0.06 ± 0.04 µm.

Asphericity Modulation Benefit in the Dominant Eyes

In the dominant eyes, an increase in the spherical aberration coefficient was expected; therefore, a positive value of c(4,0) due to induced corneal steepening at the optical zone edge was noted. This has been confirmed (Δc(4,0) = 0.01 ± 0.08), even though there was no statistically significant difference between the value of the preoperative and postoperative corneal aberration coefficient at 6 months (0.12 ± 0.06 vs 0.13 ± 0.07 µm; P = .43). However, there was a trend toward an increase in this coefficient because the Δc(4,0) was positive. No change in asphericity was applied in the dominant eyes, where the emmetropia was aimed for in the studies by Courtin et al,18 Leray et al,14 and Wang et al.25 Our value of positive spherical aberration in the dominant eyes, compared to the negative results in the aforementioned studies, is highlighted by looking at the design of multifocal contact lenses with distance central vision. The positive spherical aberration of 0.14 ± 0.07 µm that we found in our study is similar to that measured by Fedtke et al.26

HOAs and Coma Variations

The induction of corneal HOAs in our study was significant at 6 months compared to the preoperative values. Saib et al7 evaluated the Supracor algorithm on the Technolas platform for central presbyopic LASIK with micro-monovision of +0.50 D in the dominant eyes over a central area of 3 mm, and also measured similar levels of aberrations induced in a 5-mm pupil. The corneal HOAs we found in our study were significant in the non-dominant eyes (0.25 ± 0.08 vs 0.32 ± 0.15) and dominant eyes (0.25 ± 0.07 vs 0.29 ± 0.10), but remained lower than those found by Saib et al.7 The total RMS corneal coma we found at 6 months postoperatively was significant for the non-dominant eyes (P = .0003) but not for the dominant eyes (P = .24). These results explain the halo phenomena reported by some patients.

Perspectives

Table B (available in the online version of this article) compares visual acuity in studies found in the literature assessing other surgical correction options. Our study shows promising results because intermediate binocular visual acuity (100% of patients had a visual acuity of 20/25 or better) and binocular near visual acuity (92.86% of patients had visual acuity of 20/25 or better) are better than those found in the literature without compromising distance binocular visual acuity (100% of patients had a visual acuity of 20/20 or better). There is some loss of CDVA in most cases of hyperopic LASIK, but our results show no loss of CDVA even with higher refractive errors.36–38 This is due to the combination of several factors. We performed larger flaps (9.6 mm) using iris recognition for cyclotorsion compensation and custom centration while targeting a refraction of +0.50 D for the dominant eye because in our experience this provides a better UDVA in hyperopic patients (unpublished data).

Comparison of Visual Acuity Using Various Surgical Correction Options

Table B:

Comparison of Visual Acuity Using Various Surgical Correction Options

Limitations

We studied the corneal aberrations in a 5-mm zone, whereas the corneal asphericity was estimated in a 6-mm zone with the OPD Scan. Other studies evaluate both parameters on a size of 6 mm, as per the American Society of Optics recommendations.39 However, this seemed to be a more sensible compromise because the maximum pupil size of our patient sample rarely exceeded 6 mm (mean mesopic pupillary diameter = 5.16 ± 0.63). A larger sample size, use of the OQAS for objective appreciation of the depth of focus via modulation transfer function curves, assessment of the contrast sensitivity, and stereoacuity testing in our patients could be beneficial in understanding the wider effects of the treatment. We noted a female majority in our study, possibly due to a greater need for a wide range of focus.40

The improved distance vision of the non-dominant eye and the improved intermediate and near vision of the dominant eye reduces the relative difference in performance between the eyes, enhancing binocular vision in patients with presbyopic hyperopia. A bilateral multifocal approach using the Custom-Q mode can attain a balanced compromise. The positive correlation between the maximum pupil diameter and the UDVA of the non-dominant eye could be related to the relative increase of the peripheral pupil diameter with reduced myopic defocus. This may be useful for refining this technique in the future.

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Corneal Total RMS Evolutiona

ParameterPreoperativeMonth 1PMonth 3PMonth 6P
SA NDE0.11 ± 0.040.09 ± 0.11.560.06 ± 0.03< .000070.06 ± 0.04.0004
SA DE0.12 ± 0.030.15 ± 0.08.0750.14 ± 0.06.0250.14 ± 0.07.12
Coma NDE0.14 ± 0.080.32 ± 0.26.00040.23 ± 0.13.00010.24 ± 0.15.0003
Coma DE0.14 ± 0.080.25 ± 0.24.020.16 ± 0.10.430.17 ± 0.14.24
HOAs NDE0.25 ± 0.080.48 ± 0.43.010.34 ± 0.15.0030.32 ± 0.15.01
HOAs DE0.26 ± 0.070.37 ± 0.17.00040.30 ± 0.09.0230.29 ± 0.10.028

Study Visit Schedulea

StepBaseline and With CLTime Since Surgery

Month 1Month 3Month 6
Informed consent×
Keratometry/IOP××
Corneal topography (Orbscan II and WaveLight Topolyzer Vario)×××
Aberrometry (OPD-Scan III and Topolyzer)××××
OQAS×
Dominant eye selection×
Objective and manifest refraction×××
Cycloplegic refraction×
Slit-lamp evaluation of anterior segment××××
Dilated funduscopy×
Monocular and binocular UDVA, UIVA, and UNVA××××
Stereoscopic vision×××
Patient questionnaire×××
Adverse event assessments××××

Comparison of Visual Acuity Using Various Surgical Correction Options

StudyBinocular Distance VABinocular Intermediate VABinocular Near VA
Current study100% ⩾ 20/20100% ⩾ 20/2592.86% ⩾ 20/25
Techniques using depth of focus ± monovision modulation
  Reinstein et al, 20112799% ⩾ 20/2595% ⩾ 6/9
  Alarcón et al, 20112190% ⩾ 20/2090% ⩾ 20/20
  Wang et al, 201625100% ⩾ 20/25100% ⩾ 20/2070% ⩾ 20/25
  Courtin et al, 20161891% ⩾ 20/2583% ⩾ 6/9
  Rouimi et al, 20192893% ⩾ 20/2082% ⩾ 20/30
Techniques using multifocal correction with peripheral near vision enhancement
  Telandro et al, 20049100% ⩾ 20/25
  Uy & Go, 200929100% ⩾ 20/2583% ⩾ 6/9
  El Danasoury et al, 2009883% ⩾ 20/2579% ⩾ 6/9
  Epstein & Gurgos, 20093067.9% ⩾ 20/2071.4% ⩾ 20/20
Techniques using multifocal correction with central near vision enhancement
  Alió et al, 20061188% ⩾ 20/2592% ⩾ 20/30
  Jackson et al, 201131100% ⩾ 20/25100% ⩾ 20/30
Hybrid techniques
  Ryan & O'Keefe, 20131078% ⩾ 20/2591% ⩾ 20/30
  Cosar & Sener, 20143236% ⩾ 20/2589% ⩾ 20/30
  Ang et al, 201633100% ⩾ 20/2593% ⩾ 20/25
  Saib et al, 20157100% ⩾ 20/2595% ⩾ 20/25
Presbymax techniques
  Uthoff et al, 2012695% ⩾ 20/2580% ⩾ 20/30
  Baudu et al, 20133474% ⩾ 20/2587% ⩾ 20/30
  Luger et al, 20153594% ⩾ 20/2094% ⩾ 6/15 +288% ⩾ 6/15 +2
  Chan et al, 2017587% ⩾ 20/2594% ⩾ 20/30
Authors

From Fondation Ophtalmologique Rothschild, Paris, France.

The authors have no financial or proprietary interest in the materials presented herein.

AUTHOR CONTRIBUTIONS

Study concept and design (NR, DG); data collection (NR, DG); analysis and interpretation of data (IS, RR, DG); writing the manuscript (NR, IS, RR, DG); critical revision of the manuscript (NR, IS, RR, DG); statistical expertise (IS); administrative, technical, or material support (RR); supervision (DG)

Correspondence: Damien Gatinel, MD, PhD, Anterior Segment and Refractive Surgery, Fondation Ophtalmologique Rothschild, 29 Rue Manin, Paris, France. Email: gatinel@gmail.com

Received: May 21, 2020
Accepted: October 08, 2020

10.3928/1081597X-20201013-03

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