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Panretinal Photocoagulation for Diabetic Retinopathy in the RIDE and RISE Trials: Not "1 and Done".
Gonzalez, VH, Wang, PW, Ruiz, CQ
Ophthalmology. 2021;(10):1448-1457
Abstract
PURPOSE To evaluate panretinal photocoagulation (PRP) treatment and re-treatment patterns in patients with diabetic retinopathy (DR) and diabetic macular edema (DME). DESIGN Post hoc analysis of the phase 3 RIDE (clinicaltrials.gov identifier, NCT00473382) and RISE (clinicaltrials.gov identifier, NCT00473330) clinical trials of ranibizumab for the treatment of DME. PARTICIPANTS Seven hundred fifty-nine patients were randomized for treatment. METHODS Panretinal photocoagulation treatment patterns and clinical experiences were assessed by baseline PRP treatment status. MAIN OUTCOME MEASURES Number and timing of on-study PRP treatment sessions undergone through month 24. Time to new proliferative event (composite end point) was also assessed. RESULTS At baseline, approximately 25% of patients in RIDE and RISE had undergone PRP treatment before enrollment (22.2%, 24.4%, and 25.4% of patients in the sham, ranibizumab 0.3 mg, and ranibizumab 0.5 mg arms, respectively). In patients without prior PRP at baseline (n = 577), 9.5% of sham-treated patients underwent 1 or more PRP treatments through month 24, compared with 1.1% and 1.6% of patients receiving ranibizumab 0.3 mg and ranibizumab 0.5 mg, respectively (P < 0.001 for both ranibizumab arms vs. sham). In patients with prior PRP at baseline (n = 182), 19.3% of sham-treated patients underwent 1 or more PRP treatments through month 24. No ranibizumab-treated patients with prior PRP at baseline required additional on-study PRP through month 24 (P < 0.001 for both ranibizumab arms vs. sham). Ranibizumab treatment also significantly reduced clinical DR progression among patients who underwent prior PRP. By month 24 in patients with prior PRP at baseline, the probability of experiencing a new proliferative event was 10.3% and 9.9% in patients receiving ranibizumab 0.3 mg and ranibizumab 0.5 mg treatment, respectively, compared with 39.4% in sham-treated patients (P < 0.0001). Overall, sham-treated patients, including those patients who were PRP naïve at baseline who went on to require PRP, experienced more clinical events than ranibizumab-treated patients. CONCLUSIONS In RIDE and RISE, PRP treatment was not a "1 and done" procedure, with on-study PRP re-treatment occurring in patients both with and without prior PRP treatment at baseline. Ranibizumab treatment reduced on-study PRP treatment and DR progression regardless of prior PRP treatment status at baseline.
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Pre-Emptive Topical Ketorolac Tromethamine 0.5% for Panretinal Photocoagulation.
Chewa Raja, JS, Singh, S, Ismail, F
Journal of ocular pharmacology and therapeutics : the official journal of the Association for Ocular Pharmacology and Therapeutics. 2021;(5):313-317
Abstract
Purpose: To evaluate the efficacy of topical ketorolac tromethamine 0.5% given pre-emptively a day before, for alleviating pain in patients undergoing panretinal photocoagulation (PRP) treatment. Methods: A controlled single-blinded study was conducted on 33 patients with diabetic retinopathy (DR; severe nonproliferative DR, proliferative DR, or advanced diabetic eye disease) who required PRP treatment in both eyes simultaneously. Each eye of the patients was randomly assigned for ketorolac tromethamine 0.5% eyedrop or placebo. Both eyedrop bottles were randomly labeled. Eyedrops were self-administered by the patients, 4 times a day before the procedure (at 6 am, 12 noon, 6 pm, and 12 midnight) and every 15 min for 1 h (4 times) before the laser. Each patient was subjected to PRP using a Visulas 532s Zeiss device set to spot size 200 μm, time 0.10 s, and ∼600 burns in each eye. The pain score was evaluated immediately after treatment in each eye independently with Scott's visual analog scale (VAS) and the McGill Pain Questionnaire (MPQ). Results: VAS pain score in ketorolac-treated eyes (median 3.0, interquatile range [IQR] ±2.5) was lower than in placebo-treated eyes (median 5.0, IQR ±3.0). Total Pain Rate Index score from MPQ was lower in ketorolac-treated eyes (median 3.0, IQR ±3.0) than in placebo-treated eyes (median 3.0, IQR ±2.5). Both pain score differences are statistically significant with P ˂ 0.05. Conclusion: Topical ketorolac tromethamine 0.5% given pre-emptively a day before is effective in alleviating pain in patients undergoing PRP treatment.
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Comparison of navigated laser and conventional single-spot laser system for induced pain during panretinal photocoagulation.
Polat, O, Inan, S, Baysal, Z, Yigit, S, Inan, UU
Lasers in medical science. 2020;(3):687-693
Abstract
To compare the panretinal photocoagulation (PRP)-induced pain response between novel navigated laser (Navilas) and conventional single-spot laser. The eyes were randomly assigned to Navilas or conventional laser. Contralateral eyes underwent PRP with the other system with 30 min resting interval. Pulse duration was 100 ms in conventional laser and 30 ms or 100 ms in Navilas and power setting was enough to create gray-white light burn on both devices. Pain response was evaluated by verbal scale (VS) (0-4) and visual analog scale (VAS) (0-10) after each PRP application. The mean age of 70 patients (140 eyes) was 62.52 ± 9.49 years. Mean power and spot numbers for Navilas and conventional laser were 291.9 ± 85.3 mW vs 368.4 ± 72.0 mW, and 375.4 ± 108.4 vs 374.2 ± 105.0 (p < 0.001 and p = 0.53, respectively). Pain scores for Navilas and conventional laser were 1.19 ± 0.73 and 1.99 ± 0.84 for VS and 2.41 ± 1.65 and 4.74 ± 2.17 for VAS (p < 0.001 and p < 0.001). More comfortable PRP is achieved with Navilas system in comparison with conventional single-spot laser system. However, small number of patients treated with same pulse duration and different contact lenses used for two systems should be taken into consideration. Besides, we did not report comparative clinical efficiency of either laser system.
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Comparison of Subthreshold 532 nm Diode Micropulse Laser with Conventional Laser Photocoagulation in the Treatment of Non-Centre Involved Clinically Significant Diabetic Macular Edema.
Bougatsou, P, Panagiotopoulou, EK, Gkika, M, Dardabounis, D, Konstantinidis, A, Sideroudi, H, Perente, I, Labiris, G
Acta medica (Hradec Kralove). 2020;(1):25-30
Abstract
BACKGROUND The aim of the study was to investigate the effect of the 532 nm (green) diode subthreshold micropulse laser (SML) in the treatment of non-centre involved clinically significant macular edema (CSME) in comparison to the conventional laser photocoagulation (CLP). METHODS A total of 60 eyes of patients diagnosed with non-centre involved CSME were randomly divided into two groups. SML photocoagulation was performed in the first group (G1), while CLP in the second one (G2). Central macular thickness (CMT) and best corrected visual acuity (BCVA) were measured prior to treatment and at 3 and 6 months after intervention. RESULTS G1 participants had significantly better CMT at 6 months after laser application (p = 0.04) compared to G2. Additionally, CMT in both groups was significantly lower 6 months after laser application in comparison to baseline values (G1: p < 0.001, G2: p = 0.002). Moreover, significant improvement was detected 6 months after SML in G1 regarding BCVA compared to values before laser treatment (p = 0.001). CONCLUSION SML was more effective than CLP in reducing CMT and improving BCVA in patients with non-centre involved CSME. Therefore, it seems that SML can be a good substitute for CLP in DME treatment if confirmed in future studies.
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Aflibercept and navigated versus conventional laser in diabetic macular oedema: a 12-month randomized clinical trial.
Blindbaek, SL, Peto, T, Grauslund, J
Acta ophthalmologica. 2020;(4):347-352
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Abstract
PURPOSE To examine the efficacy of intravitreal aflibercept and navigated laser as compared to intravitreal aflibercept and conventional laser in diabetic macular oedema (DME) treatment. METHODS In 12-month randomized clinical trial, 48 eyes of 37 patients with centre-involved DME at Odense University Hospital were randomized 1:1 to receive three monthly injections of aflibercept followed by navigated (group A) or conventional (group B) focal/grid laser. From month four through twelve, patients were examined monthly, and additional injections were given pro re nata (PRN) (central retinal thickness [CRT]>20% from lowest measurement or loss in visual acuity [VA]>5 Early Treatment Diabetic Retinopathy Study [ETDRS] letters compared with baseline). Outcome measures; (1) percentage of eyes that needed additional injections after laser in group A and B, (2) mean number of injections in group A and B, and (3) mean change in VA and CRT in group A and B. RESULTS In the PRN phase, 60.5% of patients needed additional injections without differences between groups A and B (58.3 versus 63.2%, p > 0.99). The mean number of injections between baseline and month 12 was 4.4 (4.2 versus 4.6, p = 0.41). From baseline to month 12, VA improved by 8.4 ETDRS letters, and CRT was reduced by 97.4 μm (+9.4 versus +7.1 letters, p = 0.17, and -83.2 versus -115.4 μm, p = 0.21). CONCLUSION No difference in need for retreatment was detected between treatment arms of aflibercept and navigated versus conventional laser.
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COMPARATIVE EVALUATION OF ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY, ULTRASOUND BIOMICROSCOPY, AND INTRAOCULAR PRESSURE CHANGES AFTER PANRETINAL PHOTOCOAGULATION BY PASCAL AND CONVENTIONAL LASER.
Lata, S, Venkatesh, P, Temkar, S, Selvan, H, Gupta, V, Dada, T, Upadhyay, AD, Sihota, R
Retina (Philadelphia, Pa.). 2020;(3):537-545
Abstract
PURPOSE To compare intraocular pressure, anterior segment optical coherence tomography, and ultrasound biomicroscopy parameters over 3 months after panretinal photocoagulation (PRP) for proliferative diabetic retinopathy after 1 of 2 sittings by conventional laser (half PRP) and a single sitting of Pattern Scan Laser (PASCAL) PRP. METHODS This was a prospective, randomized, interventional study. All tests were performed at baseline, and at 1, 6, and 24 hours, and 1, 4, 8, and 12 weeks after PRP. RESULTS The intraocular pressure at 1 hour and 6 hours after PRP was significantly raised in both groups. Mean intraocular pressure was 21.17 ± 4.01 mmHg after PASCAL and 17.48 ± 3 mmHg after conventional laser at 1 hour, P < 0.001. On anterior segment optical coherence tomography, conventional laser PRP caused a more significant narrowing of angle-opening distance (AOD750) and trabecular-iris space area (TISA 500), P = 0.03 and 0.04, respectively, on Day 1. Ultrasound biomicroscopy showed a significantly narrow angle in both groups on Day 1. A significant increase in ciliary body thickness was observed in both groups, with 57.1% of PASCAL and 100% of conventionally treated eyes showing ciliary effusion on Day 1 that decreased but persisted for the next 3 months. CONCLUSION Performing PRP in sittings, prescribing previous glaucoma medications in patients at risk, and recording intraocular pressure an hour after the PRP could decrease complications.
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Can subthreshold micropulse yellow laser treatment change the anti-vascular endothelial growth factor algorithm in diabetic macular edema? A randomized clinical trial.
Kanar, HS, Arsan, A, Altun, A, Akı, SF, Hacısalihoglu, A
Indian journal of ophthalmology. 2020;(1):145-151
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PURPOSE To compare the efficacy of subthreshold micropulse yellow laser (SMYL) and intravitreal aflibercept injection (IAI) combination therapy with IAI monotherapy in the treatment of diabetic macular edema (DME) and to evaluate the number of injections and SMYL sessions required. METHODS This prospective study compared a group of 28 patients treated with a combination of SMYL and IAI with a group of 28 patients treated only with IAI. All patients initially received 3 monthly IAIs, and the monotherapy group was given additional injections as needed. The combination therapy patients additionally received SMYL after the loading phase. The primary outcome measures were the change in the best-corrected visual acuity (BCVA) and central macular thickness (CMT) from baseline to month 12; the secondary outcomes were the mean number of required injections and SMYL sessions. RESULTS In the monotherapy group, the BCVA improved from 0.38 ± 0.10 to 0.20 ± 0.10 logMAR; in the combination group, BCVA improved from 0.40 ± 0.09 to 0.17 ± 0.06 logMAR at the end of the 12th month. The CMT was reduced from 451.28 ± 44.85 to 328.8 ± 49.69 μm in the monotherapy group and from 466.07 ± 71.79 to 312.0 ± 39.29 μm in the combination group. Improvement of the mean BCVA and reduction of the mean CMT were similar in each group. The combination group required significantly fewer injections (3.21 ± 0.41 vs 5.39 ± 1.54; P < 0.001). By month 12, 75% of patients in the monotherapy group had required additional IAIs when compared with 16% in the combination group (P < 0.001). CONCLUSION SMYL combination therapy demonstrated significant visual improvements in patients with DME. In the combination group, the retreatment rate and number of required injections were significantly lower compared with the IAI monotherapy group.
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Alterations in retinal arteriolar microvascular structure associate with higher treatment burden in patients with diabetic macular oedema: results from a 12-month prospective clinical trial.
Blindbaek, SL, Peto, T, Grauslund, J
Acta ophthalmologica. 2020;(4):353-359
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PURPOSE This study was based on data from a 12-month prospective clinical trial and aimed to examine changes in retinal microvascular structure in eyes treated with intravitreal aflibercept in combination with focal/grid laser photocoagulation for diabetic macular oedema (DME). METHODS We included 32 treatment naïve eyes of 22 patients with centre involving DME. The treatment algorithm comprised a loading phase of three monthly injections of aflibercept and focal/grid laser photocoagulation [baseline (BL)-month 3 (M3)] followed by a pro re nata (PRN) aflibercept phase until month 12 (M12). Eyes were divided into groups with and without need for PRN treatment after loading. Parameters of retinal microvascular structure were measured in 45° optic disc centred fundus images at BL, M3 and M12 using a semi-automated software (VAMPIRE®, Vessel Assessment and Measurement Platform for Images of the Retina, Universities of Dundee and Edinburgh, UK). RESULTS A significant decrease in retinal arteriolar calibre was demonstrated at both M3 (-11.2 μm, p = 0.005) and M12 (-11.5 μm, p = 0.04) as compared to BL in eyes that needed PRN treatment during follow-up. In contrast, arteriolar calibre remained unchanged in eyes without need for PRN treatment (M3: -1.6 μm, p = 0.79 and M12: -7.0 μm, p = 0.22). For retinal venules, vessel calibre decreased both in eyes with and without need for PRN therapy at M3 (-9.5 μm, p = 0.01 and -11.6 μm, p = 0.01) as well as at M12 (-15.6 μm, p = 0.001 and -11.0 μm, p = 0.04). CONCLUSION Early changes in retinal arteriolar calibre are associated with an increased treatment burden during the first year of DME treatment.
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Outcomes in Patients with Diabetic Macular Edema Requiring Cataract Surgery in VISTA and VIVID Studies.
Moshfeghi, AA, Thompson, D, Berliner, AJ, Saroj, N
Ophthalmology. Retina. 2020;(5):481-485
Abstract
PURPOSE To evaluate the impact of cataract surgery on visual and anatomic outcomes in patients with diabetic macular edema treated with intravitreal aflibercept injection (IAI) or laser control and who did not require rescue therapy. DESIGN Post hoc analysis of 2 phase 3 trials, Study of Intravitreal Aflibercept Injection in Patients with Diabetic Macular Edema (VISTA) and Intravitreal Aflibercept Injection in Vision Impairment Due to DME (VIVID). PARTICIPANTS Fifty-four patients (laser treatment, n = 11; IAI, n = 43) who underwent cataract surgery during the study period. METHODS In VISTA and VIVID, patients received IAI 2 mg every 4 weeks, IAI 2 mg every 8 weeks after 5 monthly doses, or laser control through week 100. Starting at week 24, if rescue treatment criteria were met, IAI patients received laser therapy, and laser therapy patients received IAI 2 mg every 8 weeks (after 5 monthly doses). Patients who received rescue treatment before cataract surgery were excluded. MAIN OUTCOME MEASURES Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) in the laser control and pooled IAI groups before and after cataract surgery. RESULTS The cumulative incidence of cataract surgery did not depend on treatment group assignment (rate ratio, = 1.517; 95% confidence interval, 0.782-2.944; P = 0.2174). At the last study visit before surgery, BCVA was 62.2 and 56.9 letters and CRT was 342 μm and 301 μm in the laser control and IAI groups, respectively. At the first study visit after cataract surgery, BCVA was improved significantly in both the laser control and IAI groups to 73.5 letters (P = 0.010 compared with last visit before surgery) and 67.2 letters (P < 0.001 compared with last visit before surgery), respectively. Corresponding change in CRT was a modest increase to 364 μm (P > 0.05 compared with last visit before surgery) and 359 μm (P = 0.013 compared with last visit before surgery), respectively. CONCLUSIONS Incidence of cataract surgery was similar in both treatment groups. Despite a modest worsening in CRT after cataract surgery, BCVA was improved in both treatment groups.
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Aflibercept plus micropulse laser versus aflibercept monotherapy for diabetic macular edema: 1-year results of a randomized clinical trial.
Abouhussein, MA, Gomaa, AR
International ophthalmology. 2020;(5):1147-1154
Abstract
PURPOSE To evaluate the role of adjuvant micropulse laser with aflibercept injections in the management of treatment naive center involving DME, looking at decreased treatment burden and increased efficacy as outcomes after 1 year. METHODS This was a prospective, single center, randomized trial that included 40 eyes (40 patients) with previously untreated center involved DME. Patients were randomly assigned to receive either aflibercept plus micropulse laser (group A) or aflibercept monotherapy (group B). RESULTS Overall, 40 patients were included in the study; they were randomized into either group A (aflibercept + micropulse; 20 patients) or group B (aflibercept monotherapy; 20 patients). The mean number of injections after the loading dose was 4.5 ± 1.4 in group A and was 5.4 ± 1.7 in group B, and the difference between both groups was statistically significant (P = 0.029). CONCLUSION Adding 577-nm micropulse laser to aflibercept is effective for treatment naïve DME and is associated with decreased number of injections.