Prophylactic PRP in Moderate NPDR

Diabetes Clinical Trial

Official title:

The Case for Selective Prophylactic Pan-retinal Photocoagulation in Moderate Non-Proliferative Diabetic Retinopathy in Ophthalmic Practice in Low- Resource Settings

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05543564
• Other study ID #: 17300819
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: March 31, 2020

Study information

• Verified date: September 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes
• Diabetic Retinopathy
• Eye Diseases
• Retinal Diseases

Intervention

Procedure:
• PRP
Single session prophylactic early Pan-retinal Photocoagulation

Locations

Country	Name	City	State
Egypt	Assiut University	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BCVA		3 months