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Single session of pattern scanning laser versus multiple sessions of conventional laser for panretinal photocoagulation in diabetic retinopathy: Efficacy, safety and painfulness.

ABSTRACT: PURPOSE:To evaluate the clinical efficiency, safety and painfulness of retinal laser photocoagulation employing a pattern scanning laser system Pascal given in a single-session versus conventional laser multiple-session treatment of the same patient with diabetic retinopathy during 12-month follow-up. METHODS:The cohort included 60 eyes in 30 patients treated at the Ophthalmology Clinic, Faculty Hospital Ostrava, from 2008 to 2013. Panretinal laser coagulation was performed on one eye using the multispot panretinal photocoagulation given in a single-session system Pascal (OptiMedica, Santa Clara, California). On the other eye laser treatment was carried out by the classic conventional multiple-session method. RESULTS:The performance of Pascal panretinal laser coagulation was evaluated as significantly less painful (visual scale of pain was 3.28 ± 1.9) than the performance of conventional photocoagulation (visual scale of pain was 3.93 ± 1.88) with similar efficiency. Distribution of progression of diabetic retinopathy in individual patients was very similar in both groups under comparison, and was strictly paired in 24 of the 30 patients at the end of 1-year follow-up. CONCLUSION:Laser photocoagulation of the retina with the use of short impulse durations and patterns in patients with diabetic retinopathy given in one session possesses similar efficiency to that of conventional retinal photocoagulation in multiple sessions. The single session treatment is also better tolerated by patients and in addition to this, it shortens the performance of the whole therapy, which potentially saves considerable funds of all subjects participating in the process of treatment. TRIAL REGISTRATION:ClinicalTrials.gov NCT03672656.

SUBMITTER: Nemcansky J

PROVIDER: S-EPMC6634372 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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Single session of pattern scanning laser versus multiple sessions of conventional laser for panretinal photocoagulation in diabetic retinopathy: Efficacy, safety and painfulness.

Nemcansky Jan J Stepanov Alexandr A Nemcanska Sabina S Masek Petr P Langrova Hana H Studnicka Jan J

PloS one 20190716 7

<h4>Purpose</h4>To evaluate the clinical efficiency, safety and painfulness of retinal laser photocoagulation employing a pattern scanning laser system Pascal given in a single-session versus conventional laser multiple-session treatment of the same patient with diabetic retinopathy during 12-month follow-up.<h4>Methods</h4>The cohort included 60 eyes in 30 patients treated at the Ophthalmology Clinic, Faculty Hospital Ostrava, from 2008 to 2013. Panretinal laser coagulation was performed on one ...[more]

PMID: 31310626

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Project description:BackgroundAs one of the severe complications of diabetes mellitus, diabetic retinopathy (DR) is the leading cause of blindness in the working age worldwide. Although panretinal photocoagulation (PRP) was standard treatment, PRP-treated DR still has a high risk of progression. Hence, this study aimed to assess the risk factors and establish a model for predicting worsening diabetic retinopathy (DR-worsening) within five years after PRP.MethodsPatients who were diagnosed with severe non-proliferative diabetic retinopathy or proliferative diabetic retinopathy and treated with PRP were included, and those patients were randomly assigned to either a training or validation cohort. The multivariate logistic regression analysis was used to screen potential risk factors for DR-worsening in the training cohort. Then the model was established after including significant independent risk factors and further validated using discrimination and calibration.ResultsA total of 271 patients were included, and 56.46% of patients had an outcome of DR-worsening. In the training cohort (n = 135), age (odds ratio [OR] = 0.94, 95% confidence interval [CI] 0.90-0.98), baseline best corrected visual acuity (logMAR) (OR = 10.74, 95% CI 1.84-62.52), diabetic nephropathy (OR = 9.32, 95% CI 1.49-58.46), and hyperlipidemia (OR = 3.34, 95% CI 1.05-10.66) were screened out as the independent risk factors, which were incorporated into the predictive model. The area under the receiver operating characteristic curve and calibration slope in the training and validation cohort were 0.79, 0.96 (95% CI 0.60-1.31), and 0.79, 1.00 (95% CI 0.66-1.34), respectively. Two risk groups were developed depending on the best cut-off value of the predicted probability, and the actual probability was 34.90% and 82.79% in the low-risk and high-risk groups, respectively (P < 0.001).ConclusionsThis study developed and internally validated a new model to predict the probability of DR-worsening after PRP treatment within five years. The model can be used as a rapid risk assessment system for clinical prediction of DR-worsening and identify individuals at a high risk of DR-worsening at an early stage and prescribe additional treatment.

Project description:IMPORTANCE:Panretinal photocoagulation (PRP) is the standard treatment for reducing severe visual loss from proliferative diabetic retinopathy. However, PRP can damage the retina, resulting in peripheral vision loss or worsening diabetic macular edema (DME). OBJECTIVE:To evaluate the noninferiority of intravitreous ranibizumab compared with PRP for visual acuity outcomes in patients with proliferative diabetic retinopathy. DESIGN, SETTING, AND PARTICIPANTS:Randomized clinical trial conducted at 55 US sites among 305 adults with proliferative diabetic retinopathy enrolled between February and December 2012 (mean age, 52 years; 44% female; 52% white). Both eyes were enrolled for 89 participants (1 eye to each study group), with a total of 394 study eyes. The final 2-year visit was completed in January 2015. INTERVENTIONS:Individual eyes were randomly assigned to receive PRP treatment, completed in 1 to 3 visits (n?=?203 eyes), or ranibizumab, 0.5 mg, by intravitreous injection at baseline and as frequently as every 4 weeks based on a structured re-treatment protocol (n?=?191 eyes). Eyes in both treatment groups could receive ranibizumab for DME. MAIN OUTCOMES AND MEASURES:The primary outcome was mean visual acuity change at 2 years (5-letter noninferiority margin; intention-to-treat analysis). Secondary outcomes included visual acuity area under the curve, peripheral visual field loss, vitrectomy, DME development, and retinal neovascularization. RESULTS:Mean visual acuity letter improvement at 2 years was +2.8 in the ranibizumab group vs +0.2 in the PRP group (difference, +2.2; 95% CI, -0.5 to +5.0; P?<?.001 for noninferiority). The mean treatment group difference in visual acuity area under the curve over 2 years was +4.2 (95% CI, +3.0 to +5.4; P?<?.001). Mean peripheral visual field sensitivity loss was worse (-23 dB vs -422 dB; difference, 372 dB; 95% CI, 213-531 dB; P?<?.001), vitrectomy was more frequent (15% vs 4%; difference, 9%; 95% CI, 4%-15%; P?<?.001), and DME development was more frequent (28% vs 9%; difference, 19%; 95% CI, 10%-28%; P?<?.001) in the PRP group vs the ranibizumab group, respectively. Eyes without active or regressed neovascularization at 2 years were not significantly different (35% in the ranibizumab group vs 30% in the PRP group; difference, 3%; 95% CI, -7% to 12%; P?=?.58). One eye in the ranibizumab group developed endophthalmitis. No significant differences between groups in rates of major cardiovascular events were identified. CONCLUSIONS AND RELEVANCE:Among eyes with proliferative diabetic retinopathy, treatment with ranibizumab resulted in visual acuity that was noninferior to (not worse than) PRP treatment at 2 years. Although longer-term follow-up is needed, ranibizumab may be a reasonable treatment alternative, at least through 2 years, for patients with proliferative diabetic retinopathy. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT01489189.

Project description:PURPOSE:To compare rates and identify predictive factors for events that represent worsening of proliferative diabetic retinopathy (PDR) in eyes treated with panretinal photocoagulation (PRP) or ranibizumab. DESIGN:Randomized clinical trial (55 United States sites). PARTICIPANTS:Three hundred ninety-four study eyes from 305 adults with PDR, visual acuity (VA) 20/320 or better, and no history of PRP. INTERVENTION:Panretinal photocoagulation or intravitreous ranibizumab injections (0.5 mg/0.05 ml). MAIN OUTCOME MEASURES:Time from randomization to a composite PDR-worsening outcome defined as the first occurrence of vitreous hemorrhage, retinal detachment, anterior segment neovascularization, or neovascular glaucoma. RESULTS:Through 2 years, the cumulative probability of worsening PDR was 42% (PRP) versus 34% (ranibizumab; hazard ratio [HR], 1.33; 99% confidence interval [CI], 0.90 to 1.98; P = 0.063). Worse baseline levels of diabetic retinopathy severity (Early Treatment Diabetic Retinopathy Study scale) were associated with increased risk of worsening PDR, regardless of treatment group (64% [high-risk PDR or worse] vs. 23% [moderate PDR or better]; HR, 3.97; 99% CI, 2.48 to 6.36; P < 0.001). In the PRP group, eyes receiving pattern scan versus conventional single-spot PRP also were at higher risk for worsening PDR (60% vs. 39%; HR, 2.04; 99% CI, 1.02 to 4.08; P = 0.008), regardless of the number of spots placed or the number of sittings to complete the initial PRP. Eyes in both groups with vision-impairing (VA 20/32 or worse) center-involved diabetic macular edema (DME) at baseline were required to receive ranibizumab for center-involved DME. Therefore the composite outcome was compared by treatment in the subgroup of eyes that did not have vision-impairing center-involved DME at baseline. For these eyes, the rate of PDR-worsening was greater with PRP than ranibizumab (45% vs. 31%; HR, 1.62; 99% CI, 1.01 to 2.60; P = 0.008). CONCLUSIONS:In eyes with PDR, ranibizumab resulted in less PDR worsening compared with PRP, especially in eyes not required to receive ranibizumab for center-involved DME. Although anti-vascular endothelial growth factor therapy requires a more frequent visit schedule than PRP, these findings provide additional evidence supporting the use of ranibizumab as an alternative therapy to PRP for PDR, at least through 2 years.

Project description:PurposeTo 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).DesignPost hoc analyses of randomized, multicenter clinical trial data.ParticipantsEyes 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.MethodsIntravitreous ranibizumab (0.5 mg/0.05 ml) or PRP.Main outcome measuresChange in visual acuity (area under the curve) and development of vision-impairing (20/32 or worse) central-involved DME over 2 years.ResultsAfter 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).ConclusionsFor 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.

Project description:Importance:Ranibizumab is a viable treatment option for eyes with proliferative diabetic retinopathy (PDR) through 2 years. However, longer-term results are needed. Objective:To evaluate efficacy and safety of 0.5-mg intravitreous ranibizumab vs panretinal photocoagulation (PRP) over 5 years for PDR. Design, Setting, and Participants:Diabetic Retinopathy Clinical Research Network multicenter randomized clinical trial evaluated 394 study eyes with PDR enrolled February through December 2012. Analysis began in January 2018. Interventions:Eyes were randomly assigned to receive intravitreous ranibizumab (n?=?191) or PRP (n?=?203). Frequency of ranibizumab was based on a protocol-specified retreatment algorithm. Diabetic macular edema could be managed with ranibizumab in either group. Main Outcomes and Measures:Mean change in visual acuity (intention-to-treat analysis) was the main outcome. Secondary outcomes included peripheral visual field loss, development of vision-impairing diabetic macular edema, and ocular and systemic safety. Results:The 5-year visit was completed by 184 of 277 participants (66% excluding deaths). Of 305 enrolled participants, the mean (SD) age was 52 (12) years, 135 (44%) were women, and 160 (52%) were white. For the ranibizumab and PRP groups, the mean (SD) number of injections over 5 years was 19.2?(10.9) and 5.4?(7.9), respectively; the mean (SD) change in visual acuity letter score was 3.1?(14.3) and 3.0?(10.5) letters, respectively (adjusted difference,?0.6; 95% CI, -2.3 to 3.5; P?=?.68); the mean visual acuity was 20/25 (approximate?Snellen equivalent) in both groups at 5 years. The mean (SD) change in cumulative visual field total point score was -330?(645) vs -527?(635) dB in the ranibizumab (n?=?41) and PRP (n?=?38) groups, respectively (adjusted difference,?208 dB; 95% CI, 9-408). Vision-impairing diabetic macular edema developed in 27 and 53 eyes in the ranibizumab and PRP groups, respectively (cumulative probabilities: 22% vs 38%; hazard ratio,?0.4; 95% CI, 0.3-0.7). No statistically significant differences between groups in major systemic adverse event rates were identified. Conclusions and Relevance:Although loss to follow-up was relatively high, visual acuity in most study eyes that completed follow-up was very good at 5 years and was similar in both groups. Severe vision loss or serious PDR complications were uncommon with PRP or ranibizumab; however, the ranibizumab group had lower rates of developing vision-impairing diabetic macular edema and less visual field loss. Patient-specific factors, including anticipated visit compliance, cost, and frequency of visits, should be considered when choosing treatment for patients with PDR. These findings support either anti-vascular endothelial growth factor therapy or PRP as viable treatments for patients with PDR. Trial Registration:ClinicalTrials.gov Identifier: NCT01489189.

Dataset Information

Single session of pattern scanning laser versus multiple sessions of conventional laser for panretinal photocoagulation in diabetic retinopathy: Efficacy, safety and painfulness.

Publications

Single session of pattern scanning laser versus multiple sessions of conventional laser for panretinal photocoagulation in diabetic retinopathy: Efficacy, safety and painfulness.

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