Health Condition 1: H350- Background retinopathy and retinalvascular changes
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Individuals with diabetes (type 1 or type 2) 2. Age more than or equal to 18 years 3. Proliferative diabetic retinopathy which the treating physician intends to manage with PRP . 4. Media clarity, pupillary dilation, and individual cooperation sufficient to administer PRP and obtain adequate fundus photographs and OCT
Exclusion criteria
Exclusion criteria: Ocular exclusion criteria 1. History of prior PRP 2. Centre involving diabetic macular edema (central subfield thickness of more than or equal to 290?m in women, 305?m in men) (OCT shall be done on Zeiss Cirrus 500) 3. History of receiving intravitreal anti-VEGF or steroid injections in the previous 4 months 4. Macular tractional retinal detachment 5. Presence of vitreous haemorrhage dense enough to preclude successful completion of PRP (as per decision of treating physician) 6. History of prior vitrectomy surgery Systemic exclusion criteria 1. Poor diabetes control (HbA1C more than 12 percent) 2. Poor systemic condition (end stage renal disease on dialysis or other diseases which the treating physician feels can have a significant contribution to the progression of diabetic retinopathy) 3. Inability to follow up at regular intervals
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Patterns of regression of retinal neovascularization 2. Completeness of PRP and the need for additional laser 3. Central subfield thickness 4. Occurrence of new onset macular edema, vitreous haemorrhage, tractional retinal detachment and epiretinal membranesTimepoint: 6 weeks, 3 months, 6 months post last PRP session | — |
Secondary
| Measure | Time frame |
|---|---|
| Completeness of PRP and the need for additional laserTimepoint: 6 weeks, 3 months, 6 months post last PRP session;Central subfield thicknessTimepoint: 6 weeks, 3 months, 6 months post last PRP session;Occurrence of new onset macular edema, vitreous haemorrhage, tractional retinal detachment and epiretinal membranesTimepoint: 6 weeks, 3 months, 6 months post last PRP session;Visual acuity differencesTimepoint: 6 weeks, 3 months, 6 months post last PRP session;Need for PPVTimepoint: 6 weeks, 3 months, 6 months post last PRP session | — |
Countries
India
Contacts
JIPMER