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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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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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Longitudinal Wide-Field Swept-Source OCT Angiography of Neovascularization in Proliferative Diabetic Retinopathy after Panretinal Photocoagulation.
Russell, JF, Shi, Y, Hinkle, JW, Scott, NL, Fan, KC, Lyu, C, Gregori, G, Rosenfeld, PJ
Ophthalmology. Retina. 2019;(4):350-361
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PURPOSE Wide-field swept-source (SS) OCT angiography (OCTA) was compared with ultrawide-field (UWF) fluorescein angiography (FA) for evaluating neovascularization (NV) before and after panretinal photocoagulation (PRP) in eyes with treatment-naive proliferative diabetic retinopathy (PDR). DESIGN Prospective, observational, consecutive case series. PARTICIPANTS Patients with treatment-naive PDR. METHODS Patients were imaged using the SS OCTA 12 × 12-mm field of view (PLEX Elite 9000; Carl Zeiss Meditec, Inc, Dublin, CA) at baseline and at 1 week, 1 month, and 3 months after PRP. Select eyes were imaged with 5 SS OCTA 12 × 12-mm scans to create posterior pole montages. Ultrawide-field fundus photography and UWF FA were obtained at baseline and 3 months after PRP. MAIN OUTCOME MEASURES Neovascularization visualized using wide-field SS OCTA and UWF FA. RESULTS From January through May 2018, wide-field SS OCTA was performed on 20 eyes with treatment-naive PDR from 15 patients. The en face SS OCTA 12 × 12-mm vitreoretinal interface (VRI) slab images showed NV at baseline in 18 of 20 eyes (90%). Of the remaining 2 eyes, the posterior pole montage captured peripheral NV in one eye, and in the other eye, no evidence of NV was detected with either UWF FA or SS OCTA. After PRP, both SS OCTA and FA demonstrated similar progression or regression of NV, but SS OCTA provided more detailed visualization of the vascular changes. CONCLUSIONS Neovascularization in PDR can be identified at baseline and imaged serially after PRP using wide-field SS OCTA. In patients with a high clinical suspicion for PDR, wide-field SS OCTA likely will be the only imaging method needed for diagnosis and longitudinal evaluation of NV.
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Five-Year Cost-effectiveness of Intravitreous Ranibizumab Therapy vs Panretinal Photocoagulation for Treating Proliferative Diabetic Retinopathy: A Secondary Analysis of a Randomized Clinical Trial.
Hutton, DW, Stein, JD, Glassman, AR, Bressler, NM, Jampol, LM, Sun, JK, ,
JAMA ophthalmology. 2019;(12):1424-1432
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IMPORTANCE The DRCR Retina Network Protocol S randomized clinical trial suggested that the mean visual acuity of eyes with proliferative diabetic retinopathy (PDR) treated with ranibizumab is not worse at 5 years than that of eyes treated with panretinal photocoagulation (PRP). Moreover, the ranibizumab group had fewer new cases of diabetic macular edema (DME) with vision loss or vitrectomy but had 4 times the number of injections and 3 times the number of visits. Although 2-year cost-effectiveness results of Protocol S were previously identified, incorporating 5-year data from Protocol S could alter the longer-term cost-effectiveness of the treatment strategies from the perspective of the health care system. OBJECTIVE To evaluate 5- and 10-year cost-effectiveness of therapy with ranibizumab, 0.5 mg, compared with PRP for treating PDR. DESIGN, SETTING, AND PARTICIPANTS A preplanned secondary analysis of the Protocol S randomized clinical trial using efficacy, safety, and resource utilization data through 5 years of follow-up for 213 adults diagnosed with PDR and simulating results through 10 years. INTERVENTIONS Intravitreous ranibizumab, 0.5 mg, at baseline and as frequently as every 4 weeks based on a structured retreatment protocol vs PRP at baseline for PDR; eyes in both groups could receive ranibizumab for concomitant DME with vision loss. MAIN OUTCOMES AND MEASURES Incremental cost-effectiveness ratios (ICERs) of ranibizumab therapy compared with PRP were evaluated for those with and without center-involved DME (CI-DME) and vision loss (Snellen equivalent, 20/32 or worse) at baseline. RESULTS The study included 213 adults with a mean (SD) age of 53 (12) years, of whom 92 (43%) were women and 155 (73%) were white. The ICER of the ranibizumab group compared with PRP for patients without CI-DME at baseline was $582 268 per quality-adjusted life-year (QALY) at 5 years and $742 202/QALY at 10 years. For patients with baseline CI-DME, ICERs were $65 576/QALY at 5 years and $63 930/QALY at 10 years. CONCLUSIONS AND RELEVANCE This study suggests that during 5 to 10 years of treatment, ranibizumab, 0.5 mg, as given in the studied trial compared with PRP may be within the frequently cited range considered cost-effective in the United States for eyes presenting with PDR and vision-impairing CI-DME, but not for those with PDR but without vision-impairing CI-DME. Substantial reductions in anti-vascular endothelial growth factor cost may make the ranibizumab therapy cost-effective within this range even for patients without baseline CI-DME. TRIAL REGISTRATION ClinicalTrials.gov identifier: NCT01489189.
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Ranibizumab Plus Panretinal Photocoagulation versus Panretinal Photocoagulation Alone for High-Risk Proliferative Diabetic Retinopathy (PROTEUS Study).
Figueira, J, Fletcher, E, Massin, P, Silva, R, Bandello, F, Midena, E, Varano, M, Sivaprasad, S, Eleftheriadis, H, Menon, G, et al
Ophthalmology. 2018;(5):691-700
Abstract
PURPOSE Comparison of the efficacy of ranibizumab (RBZ) 0.5 mg intravitreal injections plus panretinal photocoagulation (PRP) versus PRP alone in the regression of the neovascularization (NV) area in subjects with high-risk proliferative diabetic retinopathy (HR-PDR) over a 12-month period. DESIGN Prospective, randomized, multicenter, open-label, phase II/III study. PARTICIPANTS Eighty-seven participants (aged ≥18 years) with type 1/2 diabetes and HR-PDR (mean age, 55.2 years; 37% were female). METHODS Participants were randomized (1:1) to receive RBZ+PRP (n = 41) or PRP monotherapy (n = 46). The RBZ+PRP group received 3 monthly RBZ injections along with standard PRP. The PRP monotherapy group received standard PRP between day 1 and month 2; thereafter, re-treatments in both groups were at the investigators' discretion. MAIN OUTCOME MEASURES The primary outcome was regression of NV total, on the disc (NVD) plus elsewhere (NVE), defined as any decrease in the area of NV from the baseline to month 12. Secondary outcomes included best-corrected visual acuity (BCVA) changes from baseline to month 12, time to complete NV regression, recurrence of NV, macular retinal thickness changes from baseline to month 12, need for treatment for diabetic macular edema, need for vitrectomy because of occurrence of vitreous hemorrhage, tractional retinal detachment or other complications of DR, and adverse events (AEs) related to treatments. RESULTS Seventy-seven participants (88.5%) completed the study. Overall baseline demographics were similar for both groups, except for age. At month 12, 92.7% of participants in the RBZ+PRP group presented NV total reduction versus 70.5% of the PRP monotherapy participants (P = 0.009). The number of participants with NVD and NVE reductions was higher with RBZ+PRP (93.3% and 91.4%, respectively) versus PRP (68.8% and 73.7%, respectively), significant only for NVE (P = 0.048). Complete NV total regression was observed in 43.9% in the RBZ+PRP group versus 25.0% in the PRP monotherapy group (P = 0.066). At month 12, the mean BCVA was 75.2 letters (20/32) in the RBZ+PRP group versus 69.2 letters (20/40) in the PRP monotherapy group (P = 0.104). In the RBZ+PRP group, the mean number of PRP treatments over month 12 was 3.5±1.3, whereas in the PRP monotherapy group, it was 4.6±1.5 (P = 0.001). No deaths or unexpected AEs were reported. CONCLUSIONS Treatment with RBZ+PRP was more effective than PRP monotherapy for NV regression in HR-PDR participants over 12 months.
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Panretinal Photocoagulation Versus Ranibizumab for Proliferative Diabetic Retinopathy: Factors Associated with Vision and Edema Outcomes.
Bressler, SB, Beaulieu, WT, Glassman, AR, Gross, JG, Melia, M, Chen, E, Pavlica, MR, Jampol, LM, ,
Ophthalmology. 2018;(11):1776-1783
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PURPOSE To identify baseline factors associated with change in visual acuity or development of vision-impairing central-involved diabetic macular edema (DME) over 2 years when treating proliferative diabetic retinopathy (PDR) with ranibizumab or panretinal photocoagulation (PRP). DESIGN Post hoc analyses of randomized, multicenter clinical trial data. PARTICIPANTS Eyes completing the 2-year visit (n = 328) or without vision-impairing central-involved DME at baseline (n = 302) in Diabetic Retinopathy Clinical Research Network Protocol S. METHODS Intravitreous ranibizumab (0.5 mg/0.05 ml) or PRP. MAIN OUTCOME MEASURES Change in visual acuity (area under the curve) and development of vision-impairing (20/32 or worse) central-involved DME over 2 years. RESULTS After multivariable model selection with adjustment for baseline visual acuity and central subfield thickness, no factors were identified as associated with change in visual acuity or development of vision-impairing central-involved DME within the ranibizumab group. In the PRP group, worse change in visual acuity was more likely with higher hemoglobin A1c level (-0.6 letters per 1% increase; 95% confidence interval [CI], -1.2 to -0.1 letters; continuous P = 0.03), more severe diabetic retinopathy (difference between high-risk PDR or worse vs. moderate PDR or better, -2.8 letters [95% CI, -5.5 to -0.2 letters]; continuous P = 0.003), and higher mean arterial pressure (difference between ≥100 mmHg vs. <100 mmHg, -2.0 letters [95% CI, -4.6 to 0.5 letters]; continuous P = 0.009). Development of vision-impairing central-involved DME was more likely with higher hemoglobin A1c level (hazard ratio [HR] per 1% increase, 1.31 [95% CI, 1.13-1.52]; continuous P < 0.001), more severe diabetic retinopathy (HR for high-risk PDR or worse vs. moderate PDR or better, 1.46 [95% CI, 0.73-2.92]; continuous P = 0.03), and the presence of cystoid abnormalities within 500 μm of the macula center (HR, 2.90 [95% CI, 1.35-6.24]; P = 0.006). CONCLUSIONS For eyes managed with PRP, higher hemoglobin A1c level and more severe diabetic retinopathy were associated with less vision improvement and an increased risk of vision-impairing central-involved DME developing. When managing PDR with ranibizumab, eyes gained vision, on average, with no baseline characteristics identified as associated with visual acuity or central-involved DME outcomes.
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Targeted Retinal Photocoagulation for Diabetic Macular Edema with Peripheral Retinal Nonperfusion: Three-Year Randomized DAVE Trial.
Brown, DM, Ou, WC, Wong, TP, Kim, RY, Croft, DE, Wykoff, CC, ,
Ophthalmology. 2018;(5):683-690
Abstract
PURPOSE To evaluate the effect of targeted retinal photocoagulation (TRP) on visual and anatomic outcomes and treatment burden in eyes with diabetic macular edema (DME). DESIGN Phase I/II prospective, randomized, controlled clinical trial. PARTICIPANTS Forty eyes of 29 patients with center-involved macular edema secondary to diabetes mellitus. METHODS Eyes with center-involved DME and Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) between 20/32 and 20/320 (Snellen equivalent) were randomized 1:1 to monotherapy with 0.3 mg ranibizumab (Lucentis, Genentech, South San Francisco, CA) or combination therapy with 0.3 mg ranibizumab and TRP guided by widefield fluorescein angiography. All eyes received 4 monthly ranibizumab injections followed by monthly examinations and pro re nata (PRN) re-treatment through 36 months. Targeted retinal photocoagulation was administered outside the macula to areas of retinal capillary nonperfusion plus a 1-disc area margin in the combination therapy arm at week 1, with re-treatment at months 6, 18, and 25, if indicated. MAIN OUTCOME MEASURES Mean change in ETDRS BCVA from baseline and number of intravitreal injections administered. RESULTS At baseline, mean age was 55 years, mean BCVA was 20/63 (Snellen equivalent), and mean central retinal subfield thickness (CRT) was 530 μm. Thirty-four eyes (85%) completed month 36, at which point mean BCVA improved 13.9 and 8.2 letters (P = 0.20) and mean CRT improved 302 and 152 μm (P = 0.03) in the monotherapy and combination therapy arms, respectively. The mean number of injections administered through month 36 was 24.4 (range, 10-34) and 27.1 (range, 12-36), with 73% (362/496) and 80% (433/538) of PRN injections administered (P = 0.004) in the monotherapy and combination therapy arms, respectively. Goldmann visual field isopter III-4e area decreased by 2% and 18% in the monotherapy and combination therapy arms, respectively (P = 0.30). CONCLUSIONS In this 3-year randomized trial of 40 eyes with DME, there was no evidence that combination therapy with ranibizumab and TRP improved visual outcomes or reduced treatment burden compared with ranibizumab alone.
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Interim Safety Data Comparing Ranibizumab With Panretinal Photocoagulation Among Participants With Proliferative Diabetic Retinopathy.
Gross, JG, Glassman, AR, Klein, MJ, Jampol, LM, Ferris, FL, Bressler, NM, Beck, RW
JAMA ophthalmology. 2017;(6):672-673
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This Research Letter compares treatment with intraviterous ranibizumab with undergoing panretinal photocoagulation for managing proliferative diabetic retinopathy.
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The Effect of Laser Panretinal Photocoagulation on Diabetic Macular Edema Using the Pascal® Photocoagulator versus the Conventional Argon Laser Photocoagulator.
Mahgoub, MM, Macky, TA
Ophthalmologica. Journal international d'ophtalmologie. International journal of ophthalmology. Zeitschrift fur Augenheilkunde. 2016;(3):137-40
Abstract
PURPOSE The aim of this study was to compare the effect of panretinal photocoagulation for proliferative diabetic retinopathy (PDR) on diabetic macular edema (DME) using a Pascal® Photocoagulator (PP) or a conventional argon laser photocoagulator (CALP). METHODS Eighty eyes with PDR and center-involving DME were randomized to PP or CALP. Both groups had baseline assessment of best-corrected visual acuity (BCVA) and were examined with optical coherence tomography and fluorescein angiography. RESULTS The mean number of laser shots for the PP and CALP groups was 1,726.10 and 752.00 at session 1 and 1,589.00 and 830.00 (p < 0.001) at session 2, respectively. The mean central foveal thickness (CFT) at baseline was 306 ± 100 and 314 ± 98 for the PP and CALP groups, respectively. At 8 weeks, the mean CFT was 332 ± 116 and 347 ± 111 for the PP and CALP groups, respectively (p > 0.05). The mean BCVA was similar during the study period with no significant difference between the groups (p > 0.05). CONCLUSION PP and CALP had similar effects on DME in PDR eyes and were equally safe with no significant increase in CFT.