Dataset Information

PASCAL laser platform produces less pain responses compared to conventional laser system during the panretinal photocoagulation: a randomized clinical trial.

ABSTRACT:

Background

Most of patients experience pain during the panretinal photocoagulation(PRP). Laser photocoagulation delivery has advanced with the introduction of pattern-scanning laser systems (PASCAL). Shorter pulse duration and less choroidal penetration believed to reduce pain during the laser treatment.

Objectives

To compare the severity of expressed pain scores in patients with PDR who underwent PRP either with PASCAL laser or conventional laser.

Methods

A total of 28 patients with a diagnosis of PDR who were scheduled for bilateral PRP therapy were enrolled into the prospective study. Both eyes were treated within the same session and while one eye was treated with PASCAL the other was treated with conventional laser randomly. Pulse duration was adjusted to 100-ms in conventional laser and 30 ms in PASCAL. The severity of pain was graded using a verbal scale and a visual analog scale (VAS).

Results

Mean age was 61.36±9.10 years. Mean verbal and VAS scores were 1.32±0.47 and 2.86±1.21 in the PASCAL laser and 2.39±0.49 and 5.75±1.35 in the conventional laser group, respectively. Differences between expressed pain scores obtained by both two scales were statistically significant (p<0.001).

Conclusion

PASCAL laser significantly alleviates pain levels possibly due to the shorter laser pulse duration and lower intensity.

SUBMITTER: Inan S

PROVIDER: S-EPMC6354857 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Publications

PASCAL laser platform produces less pain responses compared to conventional laser system during the panretinal photocoagulation: a randomized clinical trial.

Inan Sibel S Polat Onur O Yıgıt Safiye S Inan Umit Ubeyt UU

African health sciences 20181201 4

<h4>Background</h4>Most of patients experience pain during the panretinal photocoagulation(PRP). Laser photocoagulation delivery has advanced with the introduction of pattern-scanning laser systems (PASCAL). Shorter pulse duration and less choroidal penetration believed to reduce pain during the laser treatment.<h4>Objectives</h4>To compare the severity of expressed pain scores in patients with PDR who underwent PRP either with PASCAL laser or conventional laser.<h4>Methods</h4>A total of 28 pat ...[more]

PMID: 30766567

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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:ImportancePanretinal 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).ObjectiveTo evaluate the noninferiority of intravitreous ranibizumab compared with PRP for visual acuity outcomes in patients with proliferative diabetic retinopathy.Design, setting, and participantsRandomized 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.InterventionsIndividual 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 measuresThe 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.ResultsMean 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 relevanceAmong 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 registrationclinicaltrials.gov Identifier: NCT01489189.

Project description:IntroductionDiabetic retinopathy (DR) is microangiopathy causing ischemia leading to proliferative diabetic retinopathy and macular edema. Panretinal photocoagulation (PRP) reverses the ischemia leading to regression of neovessels. Most previous studies showed the large vessel effects of PRP, while optical coherence tomography angiography (OCTA) allowed noninvasive quantification of microvascular retinal changes.AimTo study the effect of PRP on microvascular retinal vessels in a detailed manner at different retinal and choroidal levels using OCTA.Patients and methodsThis study was a prospective interventional study. 30 eyes of 18 diabetic patients with PDR were included. All patients were evaluated clinically and with OCTA (Avanti RTVue-XR system, Optovue) to evaluate superficial and deep vessels density (VDs), choroidal flow, and FAZ area before PRP (base line) and 1 month and 6 months after PRP.ResultsPRP improved vessels density at superficial (SCP), deep (DCP), and choriocapillaris levels. Foveal vessel density at SCP and DCP were statistically significantly increased. SCP was 28.76 ± 2.56 at base line and was increased to 29.84 ± 2.47 and 30.89 ± 2.20 after 1 month and after 6 months, respectively. DCP was 34.08 ± 5.59 at base line and was increased to 34.93 ± 5.66 and 36.09 ± 5.62 after 1 month and after 6 months, respectively. Foveal choriocapillaris was statistically significantly increased from 63.04 ± 2.66 at base line to 63.48 ± 2.65 and 63.98 ± 2.78 after 1 month and 6 months, respectively. Choroidal flow was increased from 1.74 ± 0.07 at base line to 1.75 ± 0.09 at 1 month which was nonsignificant (P = 0.72), but it was significantly increased to 1.87 ± 0.27 6 months after PRP (P = 0.009). FAZ area was significantly improved after PRP. FAZ area was decreased from 0.56 ± 0.27 at base line to 0.50 ± 0.21 after 1 month and to 0.46 ± 0.21 after 6 months.ConclusionOCTA parameters were significantly improved by PRP in PDR patients, possibly due to redistribution of blood in occluded capillary plexuses.Trials registryNCT04976361.

Project description:ImportanceThe Diabetic Retinopathy Clinical Research Network Protocol S randomized clinical trial results suggest that ranibizumab is a reasonable treatment alternative to panretinal photocoagulation (PRP) when managing proliferative diabetic retinopathy (PDR), with or without concomitant baseline diabetic macular edema (DME). However, ranibizumab injections are costly. Thus, it would be useful to examine the relative cost-effectiveness of these 2 treatment modalities.ObjectiveTo evaluate incremental cost-effectiveness ratios of 0.5-mg ranibizumab therapy vs PRP for PDR.Design, setting, and participantsPreplanned secondary analysis using efficacy, safety, and resource utilization data through 2 years of follow-up at 55 US sites for 213 adults with PDR. Data were collected from February 2012 to January 2015.InterventionsIntravitreous 0.5-mg ranibizumab at baseline and as frequently as every 4 weeks based on a structured retreatment protocol or PRP at baseline for PDR. Eyes in both groups could receive ranibizumab for concomitant DME.Main outcomes and measuresIncremental cost-effectiveness ratios of ranibizumab compared with PRP evaluated within 2 prespecified subgroups for the study eye: with baseline vision-impairing (Snellen equivalent 20/32 or worse) DME and without baseline vision-impairing DME.ResultsThe study included 305 adults with PDR, the mean age was 52 years, 44% were women, and 52% were white. Of the 46 participants with PDR and vision-impairing DME at baseline, 21 were assigned to the ranibizumab group and 25 to the PRP group (plus ranibizumab for DME). Among the remaining participants without baseline vision-impairing DME, 80 and 87 were in the ranibizumab and PRP groups, respectively. For participants with and without baseline vision-impairing DME, the incremental cost-effectiveness ratios of ranibizumab therapy compared with PRP were $55 568/quality-adjusted life-year and $662 978/quality-adjusted life-year, respectively, over 2 years.Conclusions and relevanceOver 2 years, compared with PRP, 0.5-mg ranibizumab as given in this trial is within the $50 000/quality-adjusted life-year to $150 000/quality-adjusted life-year range frequently cited as cost-effective in the United States for eyes presenting with PDR and vision-impairing DME, but not for those with PDR without vision-impairing DME.Trial registrationClinicaltrials.gov Identifier: NCT01489189.

Dataset Information

PASCAL laser platform produces less pain responses compared to conventional laser system during the panretinal photocoagulation: a randomized clinical trial.

Background

Objectives

Methods

Results

Conclusion

Publications

PASCAL laser platform produces less pain responses compared to conventional laser system during the panretinal photocoagulation: a randomized clinical trial.

Similar Datasets

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