Prophylactic PRP in Moderate NPDR

Completed

• Conditions: Diabetic Retinopathy; Eye Diseases; Diabetes

• Registration Number: NCT05543564
• Lead Sponsor: Assiut University

Brief Summary

Diabetic retinopathy (DR) is a challenge to ophthalmic practice in communities with poor socioeconomic development. The COVID 19 pandemic has accentuated the challenge. DR is one of the leading causes of vision loss worldwide, estimated to account for 1.25% of moderate to severe visual impairment and 1.07% of blindness. Pan retinal photocoagulation (PRP) remains the gold standard treatment for preventing visual loss in PDR. Scatter photocoagulation is not recommended for eyes with mild or moderate non-proliferative diabetic retinopathy (NPDR) provided careful follow-up can be maintained,. When retinopathy is more severe, scatter photocoagulation should be considered and should not be delayed if the eye has reached the high-risk proliferative stage. As many as 27% of patients with moderate NPDR are estimated to progress to PDR in 1 year; therefore, they should be seen every 4 to 8 months. This ideal, good as it is, is not what ophthalmic practice has to deal with in communities of low-resource settings, where patients often seek medical advice due to visual complaints from the complications of PDR without being diagnosed in the non-proliferative stage or high risk PDR. Screening protocols are not followed, a situation aggravated during the COVID pandemic lockdown.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-01
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2022-09
• Study First Submitted: 2022-09-14
• Study First Submitted QC: 2022-09-14
• Last Update Submitted: 2022-09-14
• Study First Posted: 2022-09-16
• Last Update Posted: 2022-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

Patients with moderate NPDR at high risk which includ:

• Patients with PDR in the other eye
• Patients whose Glycosylated Haemoglobin (HbA1c) more than 8 %.
• Patients with early cataract
• Patients on regular renal dialysis or with impaired renal function
• Patients with restricted mobility because of neurological or orthopedic conditions
• Patients dependent on others, including old age.
• Women in rural areas, who are dependent on the accompaniment of a male relative.

Exclusion Criteria

• Any patient who or whose relatives confirmed their attendance for regular follow-up according to the planned schedules after being informed of the possible complications which could happen if he or she did not attend.
• Patients with clinically significant macular edema (CSME).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
BCVA	3 months

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt