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临床试验/CTRI/2025/07/091369
CTRI/2025/07/091369尚未招募不适用

Panretinal photocoagulation induced alterations in accommodation, pupillary parameters and contrast sensitivity: A prospective study in patients with proliferative diabetic retinopathy

Sankara eye hospital, Shivamogga1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年8月13日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
50
试验地点
1
主要终点
1 To measure the change in pupil size in photopic, mesopic and scotopic illumination conditions after PRP

研究概览

简要总结

Diabetic retinopathy is a serious eye disease caused by diabetes, where high blood sugar levels damage the blood vessels in the retina. Oxidative stress induced hyperglycemia is the key event in the pathogenesis of diabetic retinopathy. This damage can lead to vision impairment and, in advanced stages, blindness. Diabetic retinopathy progresses through various stages as non proliferative diabetic retinopathy NPDR and proliferative diabetic retinopathy PDR. Panretinal photocoagulation PRP is a type of laser treatment used to reduce the risk of severe vision loss in patients with proliferative diabetic retinopathy PDR or other retinal diseases. It involves applying controlled laser burns to peripheral retina, promoting selective photocoagulation, significantly reduces the oxygen demand of peripheral retina, leading to decrease production of vascular endothelial growth factor(VEGF) and other angiogenic factors. The  study will evaluate the effect of PRP on accommodation, pupillary parameters and contrast sensitivity before PRP sitting , 1 month and 3 month after completion of PRP. The pupillary parameters will be assessed in photopic, mesopic and scotopic illumination conditions.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • 1 Eyes with proliferative diabetic retinopathy requiring panretinal photocoagulation 2 Patients willing to give consent for study and follow up 3 Eyes with pupils reacting to light.

排除标准

  • 1 Macular edema requiring anti-VEGF therapy 2 Eyes with pupillary abnormalities such as coloboma, iris atropy, rubeosis iridis, sectoral iris loss 3 Eyes with hazy media 4 Eyes with other retinal disorders or optic nerve damage 5 Eyes requiring surgery for advanced diabetic eye disease 6 Past history of cataract surgery 7 Eyes developing vitreous hemorrhage after PRP within 4 months 8 Eyes presenting with posterior synechiae 9 Eyes with non-reacting pupils 10 Eyes with traumatic mydriatic pupils 11 Eyes presenting with pseudoexfoliation syndrome 12 Eyes developing macular edema after PRP (even after 1 month or 1st PRP sitting) 13 Eyes undergoing any surgical interventions before or in between follow-up.

结局指标

主要结局

1 To measure the change in pupil size in photopic, mesopic and scotopic illumination conditions after PRP

时间窗: Recorded before 1st PRP sitting then follow-up 1 month and 3 month after completion of PRP.

2 To measure the change in amplitude of accommodation and change in near point of accommodation following PRP

时间窗: Recorded before 1st PRP sitting then follow-up 1 month and 3 month after completion of PRP.

3 To measure the change in contrast sensitivity following PRP

时间窗: Recorded before 1st PRP sitting then follow-up 1 month and 3 month after completion of PRP.

次要结局

未报告次要终点

研究者

发起方
Sankara eye hospital, Shivamogga
申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Prajakta Pawar

Sankara eye hospital, Shivamogga

研究点 (1)

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