Central serous chorioretinopathy (CSC) is the fourth most common nonsurgical retinopathy,1 characterized by serous retinal detachment(s) and often associated with serous pigment epithelial detachment(s).2 It is known to be self-resolving in most cases without significant visual loss.1,3–5 However, refractoriness to treatment and chronicity is not uncommon, which can lead to permanent diminution in visual acuity.6–8 It has been reported that eyes with CSC start developing photoreceptor atrophy as early as 4 months after the onset of symptoms.4 Therefore, active management is advocated in cases of CSC that do not resolve by 3 months. However, presence of subretinal fluid (SRF) for even 3 to 4 months causes temporary or permanent compromise in contrast sensitivity.9,10 Photoreceptor cell death has been reported in experimental models and human patient samples to be immediately induced as early as 12 hours and to peak at around 2 to 3 days after retinal detachment.11–13 Therefore, early resolution of neurosensory detachment could be preferred to prevent damage to photoreceptors. We hypothesized that early laser photocoagulation of leak in eyes with acute CSC (less than 2 months) could be beneficial for early resolution of neurosensory detachment with better quality of vision.
There is no recent literature on the role of early focal laser photocoagulation in altering the course of this condition while evaluating the factors affecting quality of vision. Here, we report the results of a prospective, randomized, controlled trial to evaluate the role of early focal laser photocoagulation in eyes with acute CSC (less than 2 months' duration) and final outcome at 6 months.
Patients and Methods
A prospective study was carried out at a tertiary care eye center in India to compare the effect of early focal laser photocoagulation with that of sham laser photocoagulation in the treatment of acute CSC with focal leak. Institutional review board approval (LEC 02-14-033) was obtained for carrying out the study.
The inclusion criteria were: age of 18 years or older; vision loss with a duration of 2 months or less due to CSC diagnosed by the presence of SRF at fovea and verified by spectral-domain optical coherence tomography (SD-OCT); and localized extrafoveal leak on fundus fluorescein angiography (FFA).
The exclusion criteria were: a history of prior treatment for CSC; absence of any leak on FFA; subfoveal leak on FFA; diffuse leak on FFA, retinal pigment epithelium (RPE) atrophy, or any other signs of chronic CSC; vitreoretinal/macular disorders other than CSC currently or in the past; any intraocular procedure in last 6 months; current steroid therapy; any media opacity likely to cause attenuation of signal strength in OCT; history of malignant hypertension; pregnancy; current treatment with systemic medication such as pioglitazones, which can cause macular edema; evidence of glaucoma; and a spherical equivalent of ±6 diopters or greater.
A detailed ocular history (onset of symptoms, previous treatment), the demography (age, gender), laterality, and systemic comorbidities (diabetes and hypertension) were recorded. A comprehensive ocular examination was done at baseline, 1 month, 3 months, and 6 months and included assessment of distance best-corrected visual acuity (BCVA) as Early Treatment Diabetics Retinopathy Study (ETDRS) letter count, low-contrast visual acuity using COMPlog, and Amslers grid check before dilatation; spherical equivalent of refractive status of the eye; slit-lamp biomicroscopy with a contact lens or non-contact lens; and indirect ophthalmoscopy. Color fundus photographs of the optic disc, macula, and temporal retina (30°) were captured with a mydriatic camera (Zeiss FF450; Zeiss Jena, Germany).
Subjects were randomized to either the laser treatment group or the sham laser group in a 1:1 ratio in block sizes of six.
The SD-OCT scans were obtained by using Cirrus HD-OCT (Carl Zeiss Meditec, Dublin, CA) after dilatation of the pupil with 0.8% tropicamide and 5% phenylephrine eye drops at every visit. The scanning protocol included high-definition (HD) five-line raster, HD single-line raster, enhanced depth imaging OCT (EDI-OCT), and macular cube. Central macular thickness (CMT) was determined automatically and analyzed by OCT software by generating images using the macular cube 512 × 128 scan over 6 mm × 6 mm area, with the cube comprising 128 horizontal examination lines of 512 A-scans each. The CMT was obtained from the 1 mm central retinal thickness area as described in the ETDRS fields corresponding to the CMT. The subfoveal choroidal thickness (CT) was measured using the EDI-OCT technique previously described by Spaide et al.14 The vertical distance between the hyperreflective line of Bruch's membrane and the innermost hyperreflective line of the chorioscleral interface was taken, and the average of the two scans (vertical and horizontal) was considered as the subfoveal CT. The height of neurosensory detachment (NSD) was measured by the vertical distance between the outermost hyperreflective margin of the detached neurosensory retina at the fovea and the hyperreflective line of the RPE. Scans with a signal strength of 6 or greater (measured on a scale of 1 to 10) were used for analysis. Damage to outer retinal structures including the inner segment-outer segment (IS/OS) junction and external limiting membrane (ELM) was evaluated at the last visit, as per the previously described technique15 in which the percentage of disruption along the IS/OS and ELM layers was measured over a length of 500 μm in either direction from the foveal center in both horizontal and vertical sections. The percentage disruption was averaged to generate a number between 0% (no disruption) and 100% (total loss of the layer in both horizontal and vertical scans).
Microperimetry (MAIA; CenterVue, Fremont, CA) was performed monocularly without mydriasis to assess the retinal sensitivity. The size of the fixation target was selected based upon the subject's visual acuity. If visual acuity was less than 6/19.5 (0.50 logMAR), the larger fixation target was selected. The 100 grid pattern was selected in the protocol to test the 5° visual field surrounding the preferred retinal loci, which is initially determined by the machine by the showing the fixation target alone for 10 seconds. The machine tests the retinal thresholds at 37 points across the 50 visual field by using a 4-2-1 staircase procedure. The eye with better visual acuity was tested first, followed by the fellow eye. Subjects were asked to repeat the test in case of low reliability index. The test was paused whenever the patient felt tired. The reliability index was based upon the fixation loss value indicated by the percentage of stimuli reported as seen when a stimulus was projected onto the optic nerve head (blind spot). The test was considered unreliable when such index was below 70%. Microperimetry was done at baseline and at 1 month, 3 months, and 6 months from baseline.16
Fundus Fluorescein Angiography
FFA was performed using fluorescein sodium 20% on the Navilas Laser System (OD-OS GmbH, Teltow, Germany) to determine the site of leakage at baseline, and at 3 months and 6 months from baseline.
Navigated Laser Photocoagulation
A treatment planning was done using the earliest phase of FFA on the Navilas system that showed a site of focal leakage as described by our group.17 Initially, the power of 577 nm yellow laser was titrated to produce a barely visible burn (mild retinal whitening) outside the vascular arcade using continuous wave ‘test’ spot size of 100 μm and 0.1 second exposure time. Following this, the navigated laser was used to place one to three spots over the area of focal leak, using similar settings.
The patients in sham laser group were positioned in the similar manner on the Navilas system and only the laser beam was switched on and fundus photographs were obtained; however, the laser source was switched off.
The low-contrast visual acuity was converted to logMAR equivalent for statistical analysis. The changes from baseline in BCVA, low-contrast BCVA, height of NSD, CMT, subfoveal choroidal thickness (SFCT), and the average retinal threshold at 1 month, 3 months, and 6 months were analyzed using the Wilcoxon signed-rank test. The changes in these parameters during follow-up were compared between the two groups using Mann-Whitney test. A P value of less than .05 was considered as statistically significant.
We evaluated 58 eyes of 58 patients with treatment-naïve CSC with a mean age of 36.96 years ± 6.55 years and an average duration of symptoms of 6.7 days ± 4.9 days. The baseline features of the cases in the two arms were comparable (Table 1).
Baseline Features of Cases in the Laser and Sham Laser Groups
All 29 eyes in the early laser group were treated with FFA-guided navigated focal laser at the site of leakage. Details about clinical characteristics of both groups at each visit are shown in Table 2. The average laser power used in laser group was 86.3 mw ± 21.6 mw. The average number of spots were 3.7 ± 1.1. There was a statistically significant improvement in the BCVA, low-contrast BCVA, and the retinal sensitivity at each visit (1 month, 3 months, and 6 months) in both the laser group and the sham laser group (P < .001 for all visits) (Table 2). Similarly, there was a statistically significant reduction in the CMT and NSD height in both groups at all three visits (P < .001 for all visits for both parameters). However, there was no significant change in the SFCT in either group at any of the visits (P < .05 at all visits) (Table 2). Percentage damage of IS/OS junction in laser group and sham group was 15.3% ± 29.9% and 17.9% ± 27.8%, respectively, with no significant difference between the groups (P = .37). Percentage damage of ELM in laser group and sham group was 6.4% ± 23.7% and 2.0% ± 10.2%, respectively, with no significant difference between the groups (P = .2).
Change in Various Parameters at Each Visit Compared to Baseline in Both Groups
Change in various parameters in both the groups in comparison to baseline are shown as Table 3. We also compared the changes in the BCVA, low-contrast BCVA, retinal sensitivity, CMT, NSD height, and SFCT in the laser group, with the change in the same parameters in the sham laser group, and found that the changes were not significantly different in the two groups (P < .05 for all parameters at all visits) (Table 3).
Comparison of Change in Parameters From Baseline in Both Groups
Four eyes in sham laser group versus only one eye in early laser group needed rescue laser at the end of 3 months (P = .16). Representative cases from each group are shown as Figure 1 and 2.
A 46-year-old male presented with a right eye relative scotoma for 7 days with best-corrected visual acuity (BCVA) of 20/30 and low-contrast visual acuity (LCVA) of 20/160. (A) Color fundus photograph showed subretinal fluid (SRF; arrowhead) in the macula. (B–C) Fundus fluorescein angiography (FFA) showed early point hyperfluorescence (arrow) with typical smoke stack pattern leakage in late phase. (D) Spectral-domain optical coherence tomography (SD-OCT) showed the presence of SRF. (E) Microperimetry revealed depressed retinal sensitivity. He was treated with navigated focal laser photocoagulation at the site of fluorescein leakage (F; arrow to small yellows dot, big yellow circle shows the no-laser zone). (G) At 6-month follow-up, his BCVA and LCVA improved to 20/20 and 20/20, respectively. Color fundus photograph of the same patient after 6 months showing resolved SRF on fundus photograph FFA (I–J) revealed no active leakage. (K) SD-OCT revealed no SRF. (L) Microperimetry map shows improved retinal sensitivity (average threshold improved from 0 dB at baseline to 24.8 dB at 6 months).
A 22-year-old female presented with diminution of vision in the left eye for 3 days with best-corrected visual acuity (BCVA) of 20/20 and low-contrast visual acuity (LCVA) of 20/40. (A) Clinical examination showed subretinal fluid (SRF; arrowhead) in the macula. (B–C) Fundus fluorescein angiogram (FFA) showed early point hyperfluorescence (arrow) with late leakage. (D) Spectral-domain optical coherence tomography (SD-OCT) showed the presence of SRF. (E) Microperimetry revealed depressed retinal sensitivity. She was treated with navigated focal laser photocoagulation at the site of fluorescein leakage (F, arrow). (G) At 6-month follow-up, her BCVA and LCVA improved to 20/20 and 20/25. Color fundus photograph of the same patient after 6 months showing resolved SRF on fundus photograph FFA (I–J) revealed no active leakage. (K) SD-OCT revealed no SRF. (L) Microperimetry map shows improved retinal sensitivity (average threshold improved from 24.5 dB to 28.5 dB).
The conventional management of acute CSC involves observation unless the condition does not resolve by 3 to 4 months after the onset of symptoms, in which case active management is advocated. Focal laser photocoagulation to the site of leakage on FFA is the traditional modality of treatment. In their prospective, randomized trial from the late 1970s, Leaver and Williams reported faster resolution of subretinal fluid (6 weeks versus 16 weeks; P < .001) in eyes with initial visual acuity of 6/12 or better after treatment with focal argon laser photocoagulation to the leakage site.18 However, they did not find a significant difference in the final visual outcome at the end of 6 months after treatment. In early 1980s, Robertson et al. reported that direct laser photocoagulation shortened the duration of CSC by approximately 2 months when compared to indirect laser and was not associated with any recurrence over 18 months, compared to 34% recurrence in the sham laser and indirect laser groups.19 Most of these studies on early laser photocoagulation in CSC were before OCT era and were based upon angiographic and clinical parameters. None of the studies evaluated the objective anatomical and functional parameters such as low-contrast visual acuity, height of NSD, CMT, SFCT, or retinal sensitivity.
We found that there was a spontaneous improvement in the BCVA, low-contrast BCVA, and a reduction in the SRF, NSD, and CMT during the natural course of the disease, with or without early laser photocoagulation. However, there was lower recurrence in the laser group (one of 29) as compared to sham laser group (four of 29), although the difference did not meet statistical significance (P = .16).
We did not find additional benefit of laser photocoagulation over natural history in acute CSC, probably because the healthy RPE in vicinity leads to faster natural recovery. Once the disease persists for a longer duration, it leads to RPE damage in surrounding area, which impedes the natural recovery and requires laser photocoagulation.
We used microperimetry to assess the retinal sensitivity, which is a precise measure of the functional outcome, in the two study arms, as the mere assessment of BCVA has been shown to underestimate the effectiveness of treatment in CSC.20 Previous studies have related retinal sensitivity on microperimetry to the status of the retinal microstructure on OCT, after resolution of CSC.21–23 Retinal sensitivity has been found to decrease with disruption in the RPE line and the IS/OS junction22 and found to be higher in eyes with intact IS/OS junction and cone outer segment tips.23 In our study, we did not find any difference in the percentage damage of the IS/OS junction or ELM between the groups at the last visit. This may have led to a comparable improvement in the average retinal threshold in both the groups of our study, indicating that early laser had no advantage over sham laser in the functional outcome at any of the visits during the 6 months of follow-up.
By using the EDI-OCT technique introduced by Spaide et al., it has been reported that SFCT is increased in eyes with CSC as compared to normal eyes.24–26 It has also been reported that the CT in CSC, which is increased at baseline, gradually decreases over the next 3 months but never reaches the normal level at the end of 1 year.26 We did not observe any significant change in the CT of eyes in either of the groups at any of the visits and between the groups.
Photodynamic therapy (PDT) with reduced fluence/dose has been shown to be an effective alternate therapy to focal laser photocoagulation, but most of these studies are on chronic CSCR. We found very few studies on the role of PDT in acute CSCR; however, those available did report a better outcome with the treatment.27–29 Subthreshold micropulse laser has also emerged as a newer alternate therapy in both acute and chronic CSCR, with the advantage of preventing collateral thermal damage to retinal tissue.30–32
The main limitation of this study is the short follow-up of 6 months. However, the trend seen in the change of parameters during the 6 months of follow-up did not point toward any difference in the further course of disease among the two groups in longer follow-up. Being a subjective psychophysics test, microperimetry results may have inter-visit variability. In addition, microperimetry has narrow dynamic range.
In conclusion, the natural course of acute CSC favors observation without early laser photocoagulation. Early laser photocoagulation did not have any benefit in anatomical or functional outcome. Observation at the acute stage of CSC appears to the safe and effective management strategy.
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Baseline Features of Cases in the Laser and Sham Laser Groups
|Laser Arm (n = 29)||Sham Laser Arm (n = 29)||P Value|
|Mean Age (Years ± SD)||40.69 ± 6.27||39.19 ± 6.88||.39|
|BCVA (Letter Count)||70.26 ± 10.96||68.23 ± 10.80||.48|
|Low-Contrast BCVA (logMAR)||0.62 ± 0.29||0.68 ± 0.34||.47|
|Retinal Sensitivity (dB)||11.25 ± 7.95||10.18 ± 6.97||.59|
|CMT (μm)||558.93 ± 205.06||546.8 ± 235.91||.84|
|NSD (μm)||384.19 ± 198.95||376.16 ± 229.88||.89|
|SFCT (μm)||262.56 ± 55.75||258.56 ± 66.94||.81|
Change in Various Parameters at Each Visit Compared to Baseline in Both Groups*
|Laser Arm||Sham Laser Arm|
|Baseline||Visit 1||Visit 2||Visit 3||Baseline||Visit 1||Visit 2||Visit 3|
|Mean BCVA (Letter Count ± SD)||70.26 ± 10.96||77.63 ± 7.48 (P = .006)||80.33 ± 7.385 (P < .001)||80.41 ± 7.02 (P < .001)||68.23 ± 10.797||76.5 ± 10.61 (P = .008)||81.35 ± 5.16 (P < .001)||81.92 ± 5.07 (P < .001)|
|Low-Contrast BCVA(logMAR)||0.62 ± 0.29||0.33 ± 0.21(P < .001)||0.20 ± 0.22(P < .001)||0.18 ± 0.21(P < .001)||0.68 ± 0.34||0.31 ± 0.21(P < .001)||0.20 ± 0.21(P < .001)||0.15 ± 0.22(P < .001)|
|Retinal Sensitivity (dB)||11.25 ± 7.95||20.44 ± 3.50(P = .001)||21.23 ± 6.10 (P = .002)||22.03 ± 6.50 (P < .001)||10.18 ± 6.97||16.57 ± 5.45 (P = .054)||19.73 ± 5.88 (P = .004)||20.18 ± 4.66 (P = .001)|
|CMT (µm)||558.93 ± 205.06||255.75 ± 87.91 (P < .001)||249.96 ± 85.06 (P < .001)||251.78 ± 113.09 (P < .001)||546.8 ± 235.91||272.56 ± 89.40 (P < .001)||267.84 ± 125.73 (P < .001)||254.04 ± 65.73 (P < .001)|
|NSD (µm)||384.19 ± 198.95||68.41 ± 71.72 (P < .001)||42.56 ± 77.58 (P < .001)||41.96 ± 116.29 (P < .001)||376.16 ± 229.88||75.42 ± 92.74 (P < .001)||71 ± 131.15 (P < .001)||46.25 ± 80.38 (P < .001)|
|SFCT (µm)||262.56 ± 55.75||255.07 ± 53.21 (P = .62)||244.14 ± 33.01 (P = .14)||250.61 ± 49.90 (P = .41)||258.56 ± 66.94||272.32 ± 68.04 (P = .47)||261.28 ± 59.38 (P = .88)||255.44 ± 63.03 (P = .87)|
Comparison of Change in Parameters From Baseline in Both Groups*
|Laser Arm||Sham Laser Arm|
|Visit 1||Visit 2||Visit 3||Visit 1||Visit 2||Visit 3|
|Change in BCVA (Letters)||7.37 ± 11.79||10.07 ± 12.26||10.15 ± 11.99||8.27 ± 14.25 (P = .40)||13.12 ± 9.90 (P = .16)||13.69 ± 11.16 (P = .135)|
|Change in Low-Contrast BCVA (logMAR)||−0.29 ± 0.34||−0.42 ± 0.31||−0.44 ± 0.34||−0.37 ± 0.31 (P = .20)||−0.47 ± 0.30 (P = .29)||−0.53 ± 0.34 (P = .18)|
|Change in Retinal Sensitivity (dB)||8.57 ± 9.07||10.73 ± 8.52||11.53 ± 8.38||5.12 ± 8.05 (P = .15)||9.55 ± 8.26 (P = .36)||10.01 ± 8.00 (P = .31)|
|Change in CMT (µm)||−303.18 ± 217.96||−308.96 ± 208.17||−308.39 ± 178.02||−274.24 ± 242.66 (P = .32)||−278.96 ± 191.17 (P = .29)||−292.76 ± 235.84 (P = .39)|
|Change in NSD (µm)||−306.31 ± 198.28||−330.31 ± 203.06||−330.92 ± 181.73||−294.88 ± 242.32 (P = .43)||−308 ± 194.26 (P = .35)||−319.6 ± 258.21 (P = .43)|
|Change in SFCT (µm)||−7.21 ± 53.99||−9.04 ± 72.56||−2.57 ± 75.86||13.76 ± 68.25 (P = .11)||2.72 ± 59.98 (P = .26)||−3.12 ± 70.17 (P = .49)|