Ophthalmic Surgery, Lasers and Imaging Retina

Clinical Science 

Predictors of Outcome During Eplerenone Therapy in Chronic Central Serous Chorioretinopathy:A Prospective, Open-Label Pilot Clinical Study

Bindu Rajesh, MS; Hitesh Agrawal, DO; Hari Kumar Peguda, BSc Optom; Jay Chhablani, MS

Abstract

BACKGROUND AND OBJECTIVE:

To assess the treatment response and predictive factors following eplerenone treatment in chronic central serous chorioretinopathy (CSCR).

PATIENTS AND METHODS:

A prospective, nonrandomized study involving fixed-dose eplerenone was conducted in 22 eyes of 11 consecutive patients with bilateral chronic CSCR. The changes in subretinal fluid (SRF), central macular thickness (CMT), and best-corrected visual acuity (BCVA) were analyzed.

RESULTS:

A significant reduction in SRF was observed in 13 of 16 eyes with baseline SRF (81.25%) at 3 months (P < .04), with complete resolution in six eyes (37.5%) at 3 months and in 10 eyes (62.5%) at 6 months (P < .006). Baseline BCVA was a significant predictor of final BCVA (P < .001), whereas 3-month SRF height was a weak but significant predictor of the 6-month height (r2 = 0.53; P = .002).

CONCLUSION:

When treated with eplerenone, chronic CSCR shows a significant reduction in SRF, with baseline BCVA and 3-month SRF height being important predictive factors.

[Ophthalmic Surg Lasers Imaging Retina. 2018;49:479–486.]

Abstract

BACKGROUND AND OBJECTIVE:

To assess the treatment response and predictive factors following eplerenone treatment in chronic central serous chorioretinopathy (CSCR).

PATIENTS AND METHODS:

A prospective, nonrandomized study involving fixed-dose eplerenone was conducted in 22 eyes of 11 consecutive patients with bilateral chronic CSCR. The changes in subretinal fluid (SRF), central macular thickness (CMT), and best-corrected visual acuity (BCVA) were analyzed.

RESULTS:

A significant reduction in SRF was observed in 13 of 16 eyes with baseline SRF (81.25%) at 3 months (P < .04), with complete resolution in six eyes (37.5%) at 3 months and in 10 eyes (62.5%) at 6 months (P < .006). Baseline BCVA was a significant predictor of final BCVA (P < .001), whereas 3-month SRF height was a weak but significant predictor of the 6-month height (r2 = 0.53; P = .002).

CONCLUSION:

When treated with eplerenone, chronic CSCR shows a significant reduction in SRF, with baseline BCVA and 3-month SRF height being important predictive factors.

[Ophthalmic Surg Lasers Imaging Retina. 2018;49:479–486.]

Introduction

Central serous chorioretinopathy (CSCR) is a disorder associated with collection of fluid under the neurosensory retina.1,2 Despite the implication of several risk factors like smoking, systemic hypertension, type A personality, autoimmune disorders, sleep disorders, pregnancy, Helicobacter pylori infection, and psychopharmacologic medication, the underlying pathophysiologic mechanism is still unclear.3,4

Recent reports and observations from animal studies along with the occurrence of CSCR in patients with primary aldosteronism support the role of mineralocorticoid pathways in the hyperdynamic choroidal circulation and thereby in the pathogenesis of CSCR.5–8 Spironolactone and eplerenone (Eptus; Glenmark Pharmaceuticals Ltd, Maharashtra, India) were the common mineralocorticoid receptor (MR) antagonists used in various reports.9–18 Eplerenone had the advantage of being more selective with higher affinity to MR and less sex hormone-related side effects. Most of the case reports were retrospective in nature, except for a few prospective trials with varying dosage regimens and follow-up protocols.13,16 We decided to conduct a prospective pilot study using a fixed-dose protocol of eplerenone in patients with chronic CSCR to assess the response to treatment and the associated predictive factors.

Patients and Methods

A prospective, nonrandomized, open-label pilot clinical study of consecutive, consenting patients diagnosed with chronic CSCR who presented to the vitreoretinal department of a tertiary care eye center in India between January 2016 and July 2016 was conducted. The study was approved by the institute's ethics committee and adhered to the tenets set forth in the Declaration of Helsinki.

The patients received in-depth explanations regarding the study, the off-label drug in use, and possible side effects. The voluntary nature of their participation and the right to withdraw any time was also stressed upon.

Chronic CSR was defined as presence of subretinal fluid persisting for 4 months or more, with or without serous pigment epithelial detachment and cystoid changes on spectral-domain optical coherence tomography (SD-OCT), and presence of widespread retinal pigment epithelium (RPE) changes in the macular region. Patients with history of choroidal neovascular membrane, media opacity preventing fundal view, any other significant ocular comorbidity that could cause of vision loss, presence of any renal pathology, hyperkalemia, and pregnancy were excluded.

Eplenerone was administered for a total of 3 months with an initial 50 mg dose daily for 1 month followed by 25 mg daily for 2 months. After treatment cessation, the patients were kept under an observation period of 3 months before they exited the study. All patients were asked for any untoward systemic symptoms and underwent a systemic examination along with baseline recording of pulse, blood pressure, serum potassium, and renal function tests, which were repeated at week 2 and at months 1, 2, and 3.

Baseline history of all patients, the best-corrected visual acuity (BCVA) after refraction, and clinical features were recorded. Diagnosis was confirmed by clinical examination and SD-OCT. Baseline fundus fluorescein angiography and indocyanine green angiography (as per physician's discretion) using HRA2 (Heidelberg Engineering, Heidelberg, Germany) was done for all patients. The height of the neurosensory detachment (NSD), choroidal thickness (CT), and the large choroidal vessel thickness (LCVT) were manually measured on OCT by a single grader (HA) using the swept-source DRI OCT Triton (Topcon, Tokyo, Japan). The height of the NSD was measured at the fovea perpendicularly from the outer surface of the NSD to the inner surface of the RPE. Measurement of LCVT was made as the perpendicular distance from the innermost aspect of the large choroidal vessel layer to the chorioscleral interface (at the fovea and at or close to 750 μm nasal and temporal to the fovea), whereas the vertical distance between the hyperreflective lines of the Bruch's membrane and the choroid-scleral interface was measured as the CT. The primary outcome measures were the resolution of NSD and reduction in central macular thickness (CMT), whereas changes in the BCVA, CT, and the LCVT were the secondary outcome measures. Predictive factors that influenced the response to treatment were also analyzed.

Statistical analyses were calculated using Excel (Microsoft, Redmond, WA) and Graph Pad Prism 5 (GraphPad Software, La Jolla, CA). All reported P values were found significant when evaluated at alpha level .05. Predictive factors for the final BCVA and the SRF height were analyzed by univariable and multivariable regression analysis.

Results

Eleven patients diagnosed with bilateral chronic CSCR, with a mean age of 46.35 years ± 10.40 years (range: 30 years to 61 years) were included in the study. The demographics are depicted in Table 1.

Demographics of Study Patients

Table 1:

Demographics of Study Patients

Among 22 eyes, 16 eyes (72.7%) showed presence of NSD at the time of inclusion in the study, whereas six eyes (27.2%) had chronic intraretinal cystoids changes. Other morphological features and the previous treatment history have been included in Table 2.

Morphological Features of the CSCR and Treatment History in Study Eyes

Table 2:

Morphological Features of the CSCR and Treatment History in Study Eyes

Initiation of eplerenone therapy led to reduction in SRF in 13 out of 16 eyes (81.25%) at 3 months. Six eyes (37.5%) had complete resolution at 3 months with no recurrence at 6 months. Seven out of 13 eyes (53.8%) showed some reduction in SRF at 3 months. However, at the 6-month follow-up, two of seven eyes had complete resolution of SRF, two eyes had further reduction in SRF when compared to 3-month SRF, and the remaining three out of seven eyes were status quo without any further reduction in SRF. Two of three eyes, with an increase in the SRF at 3 months, had complete resolution at 6 months, whereas one eye only showed a reduction at 6 months.

The reduction in the SRF height at 3 months and at 6 months was found to be significant when compared to the baseline (Table 3). Similarly, there was significant reduction in the SRF height at 6 months when compared to the 3-month SRF height (P < .05). However CMT reduction at 6 months was not significant (P = .10) when compared to the CMT at 3 months, though the CMT reduction at 3 months and 6 months was significant when compared to the baseline CMT (Table 3).

Average OCT Parameters of Patients Following Eplerenone Therapy at Baseline, 3 Months, and 6 Months, Along With Their Statistical Significance

Table 3:

Average OCT Parameters of Patients Following Eplerenone Therapy at Baseline, 3 Months, and 6 Months, Along With Their Statistical Significance

None of the eyes had an increase in SRF after treatment cessation.

Intraretinal cystoids were present in six eyes at baseline with a resolution in three eyes and persistence in three other eyes at 3 months; however, a recurrence was observed in all eyes following stoppage of therapy (Figure).

A 62-year-old female presented with blurring of vision for a 6-month duration in both eyes. Her best-corrected visual acuity (BCVA) was 20/200 and 20/25 in right and left eyes, respectively. Clinical examination and angiography showed signs of chronic central serous chorioretinopathy with presence of shallow subretinal fluid and chronic cystoid changes on swept-source optical coherence tomography (SS-OCT) in her right eye and shallow subretinal fluid and a pigment epithelial detachment in her left eye (top panel). She was started on oral eplerenone 50 mg daily for 1 month, then 25 mg daily for 2 months. At the 3-month follow-up, her BCVA improved to 20/125 and 20/20 in the right and left eyes, respectively, with significant improvement on SS-OCT (middle panel) and treatment was stopped. Six-month follow-up after cessation of treatment revealed a reduction in her right eye BCVA to 20/200, whereas left eye remained at 20/20. SS-OCT revealed signs of recurrence of the disease (bottom panel).

Figure.

A 62-year-old female presented with blurring of vision for a 6-month duration in both eyes. Her best-corrected visual acuity (BCVA) was 20/200 and 20/25 in right and left eyes, respectively. Clinical examination and angiography showed signs of chronic central serous chorioretinopathy with presence of shallow subretinal fluid and chronic cystoid changes on swept-source optical coherence tomography (SS-OCT) in her right eye and shallow subretinal fluid and a pigment epithelial detachment in her left eye (top panel). She was started on oral eplerenone 50 mg daily for 1 month, then 25 mg daily for 2 months. At the 3-month follow-up, her BCVA improved to 20/125 and 20/20 in the right and left eyes, respectively, with significant improvement on SS-OCT (middle panel) and treatment was stopped. Six-month follow-up after cessation of treatment revealed a reduction in her right eye BCVA to 20/200, whereas left eye remained at 20/20. SS-OCT revealed signs of recurrence of the disease (bottom panel).

A reduction in the choroidal thickness by an average of 16 μm (range: 10 μm to 173 μm) following initiation of eplerenone therapy was noted in 14 eyes (63.6%), whereas four eyes did not show any change, and four showed an increase in choroidal thickness at 3 months. The LCVT showed an average decrease of 18 μm (range: 10 μm to 202 μm) at 3 months, whereas cessation of the drug resulted in rebound average increase by 44 μm (range: 10 μm to 309 μm). Although changes in CT at 3 months and 6 months and a decrease in the LCVT at 3 months were not statistically significant (Table 3), the rebound increase in LCVT following cessation of drug was significant (233.13 μm ± 140 μm vs. 188±73.8 μm; P = .025).

The average logMAR BCVA in our patients improved from the baseline average logMAR value of 0.27 to 0.19 (Snellen equivalent: 20/40 to 20/30) at 3 months (P = .47) and remained unchanged (average logMAR value of 0.19; ie, Snellen equivalent of 20/30) at 6 months (P = .48) following treatment cessation. Only one eye had a worsening of the visual acuity at 3 months due to increase in the SRF while on eplerenone, which improved gradually as the fluid reabsorbed at 6 months.

On analyzing the treatment predictors, the baseline BCVA was found to be significant predictor of the 3 months (r2 = 0.62; P < .0001) and 6 months (r2= 0.6; P < .0001) BCVA . The baseline SRF height was a poor predictor of the SRF height at 3 months (r2= 0.14; P = .07); however, the 3-month SRF height was a weak but significant predictor of the 6-month SRF height (r2= 0.53; P = .002). The duration of the disease, baseline SRF height, CMT, CT, or LCVT did not have any noticeable effect on the response to eplerenone.

Renal function tests and serum electrolyte assessment in all patients were normal, and there were no untoward symptoms or systemic side effects noted in any of the patients during the course of the treatment.

Discussion

Our study reports reduction of SRF in more than 80% of eyes at 3 months, with complete resolution in more than a third of patients at 3 months and more than two-thirds at 6 months. Twenty-five percent of the patients in the study by Bosquet et al. had complete resolution of SRF at 1 month, whereas 67% resolved by 3 months.9 The complete resolution of neurosensory detachment on eplerenone therapy was seen in varying degrees in different reports (36%: Leisser et al.; 29%: Cakir et al.; 50% eyes: Dariuch et al.; 64%: Salz et al.)11–18 Contrary to the reports by Ghadiali et al.12 and Leisser et al.,15 which did not observe any significant change in the CMT, we observed a significant reduction in the CMT at 3 months similar to few other reports.7,9,14,18

All our patients responded to the treatment; however, three of our cases showed an initial increase at 3 months followed by a gradual reduction / resolution of SRF at 6 months, probably suggesting either a slow response or chronicity of the condition. Cakir et al. noted that 25% of their cases failed to respond to treatment despite a sustained daily dosage of 50 mg. Worsening or increase of SRF has also been noted by Singh et al in a single case; however, they have not commented about the further course of the condition in their patient.19

As 50 mg/day was found to be the lowest efficacious drug dose with improved risk benefit ratio being noted in the dose range of 25mg/day to 50 mg/day,20 we preferred to start our patients on initial 50 mg/day for 1 month. Most studies12,13,18 started on a small dose of 25 mg/day for 1 week and then 50 mg/day for 3 months, in accordance with the pilot study by Bosquet et al.9 Kapoor et al. started their patients on 50 mg twice-per-day dosage and even increased it to 50 mg three-times-per-day in patients who had persistent SRF.14

Leisser et al. observed that none of their cases had any relevant improvement between 8 weeks and 12 weeks, suggesting 8 weeks to be an optimal time to stop the treatment if no desired response is obtained.15 However, we suggest that it would be advisable to continue the treatment for at least 3 months to 4 months before deciding nonresponsiveness, as our study cases improved only after 3 months treatment. Salz et al. had continued a daily dose of 50 mg eplerenone in their patient with reduced but persistent SRF with resolution at 12 months.11 Though we followed a fixed protocol, we believed that further continued treatment in our persistent cases could have possibly resulted in further improvement, and therefore a case-by-case approach would be more beneficial, as suggested by Ryan et al.10

Change in visual acuity despite SRF reduction was insignificant in our study, similar to findings by Ghadiali et al.,12 whereas Leisser et al.15 observed visual acuity improvement despite incomplete resolution in 73% cases of their cases, similar to reports by Bosquet et al.9 and Gergely et al.13

In our study, the baseline BCVA was a significant predictor of the 3- and 6-month BCVA, and the 3-month SRF height was an important predictor of the 6-month SRF height. Gergely et al. found disease duration and initial choroidal thickness to be significant predictors for SRF decrease, unlike our findings and those of Cakir et al., wherein no such relationship was observed.13,18

Zhao et al. noticed reduction in the choroidal vessel dilatation 2 weeks after starting eplerenone in one patient, and their animal studies suggest that MR antagonist can reverse choroidal dilatation.6 They had also treated two cases of chronic CSCR for 5 weeks with effecting lasting for 5 months. Pichi et al. found that only spironolactone caused a mean reduction of about 14 μm in the outer choroidal vessels whereas, on the contrary, eplerenone caused an increase in diameter by 4.4 μm, suggesting that although both MR antagonists act on the retina, only spironolactone had visible action on the choroid.16 The decrease in the LCVT on eplerenone therapy in our study and its significant increase following cessation of eplerenone therapy do ascertain the action of eplerenone on the choroidal vasculature in contrary to the report by Pichi et al. Though there was a rebound increase in the LCVT in our study, there was no corresponding increase in the SRF height on cessation of drug.

We observed eplerenone to be systemically safe in the dose ranges of 25 mg to 50 mg; however, we would still advise monitoring blood parameters and caution in compromised patients or in those who need long duration. Most of the side effects noted in other studies were tolerable ones like fatigue, dizziness, somnolence, and mild bowel irritation, whereas some also reported hyperkalemia, increased liver parameters, and worsening of renal functions in a nephrectomized patient.6,15 Despite the increased dosage to 50 mg three times daily, the side effects noted in the series by Kapoor et al. were very minimal when compared to those from spironolactone.14 Studies for cardiovascular indications have also shown that response of patient subsets to eplerenone is not uniform and, hence, select groups may require additional monitoring with dose adjustments.21 Eplerenone is as efficacious as other treatment modalities like oral spironolactone, photodynamic therapy, and anti-vascular endothelial growth factor, or a combination therapy for chronic CSCR as depicted in Table 4.22–25

Summary of Published Studies on Various Treatment Modalities for Central Serous ChorioretinopathySummary of Published Studies on Various Treatment Modalities for Central Serous Chorioretinopathy

Table 4:

Summary of Published Studies on Various Treatment Modalities for Central Serous Chorioretinopathy

Limitations of the study included small sample size, manual measurement of CT and LCVT by single observer, lack of a control group, and a shorter follow-up period after stoppage of drug. Strengths include a prospective study with fixed-dose regimen and fixed follow-up schedule, meticulous monitoring of blood parameters at regular intervals to ascertain safety aspect, and assessment of choroidal changes along with macular thickness and subretinal fluid changes during treatment and following cessation.

In conclusion, when treated with eplerenone, chronic CSCR shows a significant sustained reduction in the SRF and CMT, with the baseline BCVA being a significant predictor of the final BCVA. The significant increase in the large choroidal vessel thickness following cessation of therapy emphasizes the effects of eplerenone on the choroidal vasculature. SRF height after 3 months of eplerenone therapy could be a predictor for long-term management and long-term follow-up of patients using this parameter may help predict and understand the pathophysiology of recurrences in these patients.

References

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  19. Singh RP, Sears JE, Bedi R, Schachat AP, Ehlers JP, Kaiser PK. Oral eplerenone for the management of chronic central serous chorioretinopathy. Int J Ophthalmol. 2015;8(2):310–314.
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  23. Lee JH, Lee SC, Kim H, Lee CS. Comparison of short-term efficacy between oral spironolactone treatment and photodynamic therapy for the treatment of nonresolving central serous chorioretinopathy. Retina. 2017Oct30. doi:. [Epub ahead of print] doi:10.1097/IAE.0000000000001913 [CrossRef]
  24. Sun X, Shuai Y, Fang W, Li J, Ge W, Yuan S, Liu Q. Spironolactone versus observation in the treatment of acute central serous chorioretinopathy. Br J Ophthalmol. 2017Oct31. doi:. [Epub ahead of print] doi:10.1136/bjophthalmol-2017-311096 [CrossRef]
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Demographics of Study Patients

ParameterNumber

No. of Patients11

No. of Eyes22

Mean Age of Patients46.36 years ± 10.40 years (range: 30 years to 61 years)

Sex of Patients
  Males9
  Females2

Systemic History
  Systemic Hypertension2
  Diabetes mellitus and systemic hypertension2
  Smoking2
  Steroid exposure1

Mean Duration of Disease44 months ± 42.5 months (range: 6 months to 120 months)

Morphological Features of the CSCR and Treatment History in Study Eyes

ParameterTotal No. of Eyes

Morphological Characteristics
  Presence of baseline subretinal fluid16
  Associated Intraretinal cystoids6
  Associated pigment epithelial detachments5

Previous Treatment History
  Nil9
  Focal laser alone2
  Micropulse laser alone2
  Multiple treatments3
  Focal laser + PDT1
  Focal laser + PDT + micropulse1
  Lucentis + micropulse + PDT1

Average OCT Parameters of Patients Following Eplerenone Therapy at Baseline, 3 Months, and 6 Months, Along With Their Statistical Significance

OCT ParametersBaseline3 Months (Results During Treatment)P Value (Baseline vs. 3 Months)6 Months (Results After Treatment Cessation)P Value (Baseline vs. 6 Months)P Value (3 Months vs. 6 Months)
Average CMT (n = 22)298.45 ± 157231.95 ± 89.2.015204.4 ± 75.8.0009.10
Average NSD height (n = 16)167 ± 176.7358.45 ± 76.57.0430.04 ± 56.41.0006.05
Average CT (n = 22)435.06 ± 94.86419.31 ± 82.9.33431.59 ± 88.57.68.22
Average LCVT (n = 22)211.5 ± 113.08188.36 ± 73.8.56233.13 ± 140.26.25.025

Summary of Published Studies on Various Treatment Modalities for Central Serous Chorioretinopathy

Authors / YearType of StudyNo. of PatientsNo. of EyesType of CSCRTreatment (Drug, Dose, Duration)Follow-UpComplete ResolutionReduction in CMT (vs. Baseline)Change in BCVA (vs. Baseline)
Our studyProspective open label1122ChronicEplerenone 50 mg, 1 month; 25mg, 2 months6 months10 of 16 (62%)Reduced significantly P= .0009Improved, but not significant
Bosquet et al. 2013Prospective, open-label1313ChronicEplerenone 25mg, 1 week; 50 mg, 1 month to 3 months6 months6 of 9 (67%)20% decrease in CMT in 70% patients, significant reduction at 1 month (P < .05) and 3 months(P< .01)Significant changeat 3 months (P< .001)
Salz et al. 2015Retrospective1414ChronicEplerenone 25 mg, 1 week; 50 mg, 3 months or until resolution3 months9 of 14 (64%)Not mentionedSignificant improvement in VA (P= .02)
Leisser et al. 2015Retrospective1111Chronic recurrentEplerenone 25 mg to 50 mg until neededAverage, 10.6 weeks (3 weeks to 38 weeks)4 (36.4%)No significant change (P = .08)73% improved, significance not stated
Gergely et al. 2016Prospective2828ChronicEplerenone 50 mg, 3 months6 months32%Significant reduction in CMT(P < .001)Slight but significant change in VA at 6 months(P< .005)
Ghadiali et al. 2016Retrospective1412Acute and chronic (94%)Spironolactone (seven of 14; 50%); Eplerenone (two of 14; 14.3%); Remaining switched12 monthsSignificant reduction at 6 months (P< .05) and 12 month (P < .035)No significant improvementSignificant improvement only at 12 months (P= .043)
Kapoor et al. 2016Retrospective3232Not mentionedSpironolactone: 12; Eplerenone: 12; Observation: 8; Treated until resolutionAverage 5.2 months (3 months to 10 months)58.3%Significant change at 1, 2, and 3 months (P< .05)Significant changeat 1.2.6 months (P< .05)
Cakir et al. 2016Retrospective2424ChronicEplerenone 25 mg a week followed by 50 mgAverage: 104 days7 (29%)Significant reduction in CMT(P< .0001)Significant change in BCVA in nonresolving group but not in atrophic group
Dariuch et al. 2016Retrospective5442ChronicEplerenone, 22; Spironolactone, 12; Switch between: two to eight6 months21 (50%)Significant reduction at 6 months (P= .0003)Significant improvement at 6 months (P= .04)
Chung et al. 2017Retrospective7777Chronic6 weekly IVB until resolution of SRF12 months52 of 77 (68%)Significant reduction (P < .05)Significant changefrom baseline(P< .001)
Lee et al. 2017Retrospective4118 of 23Nonresolving CSCRSpironolactone:18 eyes; Half-dose PDT: 23 eyes3 months7 of 18 (34% SPR) 13 of 23(56% PDT)Both groups significant reduction(P< .001)Significant improvement both groups at 3 months only (P=.023; P= .016)
Sun X et al. 2017Prospective, RCT1818AcuteSpironolactone for 2 months vs. observation2 months10 of 18 (55.6%)Significant decrease (P< .05)Significant change from baseline (P< .05)
Asahi et al. 2017Retrospective88Unresponsive CSCRFull dose, half fluence PDT+ anti-VEGF12 months8 of 8Significant decrease in CMT (P< .001)Significant improvement in BCVA (P= .019)
Authors

From Giridhar Eye Institute, Kerala, India (BR); and Smt. Kanuri Santhamma Centre for Vitreo Retinal Diseases, LV Prasad Eye Institute, Telangana, India (HA, HKP, JC).

The authors report no relevant financial disclosures.

Address correspondence to Jay Chhablani, MS, Smt. Kanuri Santhamma Retina Vitreous Centre, L.V. Prasad Eye Institute, Kallam Anji Reddy Campus, Banjara Hills, Hyderabad 500 034, India; email: jay.chhablani@gmail.com.

Received: May 29, 2017
Accepted: February 27, 2018

10.3928/23258160-20180628-03

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