Prophylactic PRP in Moderate NPDR

• Sponsor: Assiut University (Other)
• Overall Status: Completed
• CT.gov ID: NCT05543564
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Actual Duration (Months): 13.9
• Patients Per Site Per Month: 4.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Eye Diseases; Diabetes; Diabetic Retinopathy	Procedure: PRP

Study Design

• Study Type: Observational
• Actual Enrollment: 68 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: The Case for Selective Prophylactic Pan-retinal Photocoagulation in Moderate Non-Proliferative Diabetic Retinopathy in Ophthalmic Practice in Low- Resource Settings
• Actual Study Start Date: Feb 1, 2019
• Actual Primary Completion Date: Mar 31, 2020
• Actual Study Completion Date: Mar 31, 2020

Outcome Measures

Primary Outcome Measures

1. BCVA [3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assiut University	Assiut		Egypt	71515

Sponsors and Collaborators

• Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Khaled Abdelazeem, Associate Professor, Assiut University
• ClinicalTrials.gov Identifier: NCT05543564
• Other Study ID Numbers: 17300819
• First Posted: Sep 16, 2022
• Last Update Posted: Sep 16, 2022
• Last Verified: Sep 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Retinal Diseases; Diabetic Retinopathy; Eye Diseases

Study Results

No Results Posted as of Sep 16, 2022