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OpenTrials
Completed

NCT Number: NCT05543564

Prophylactic PRP in Moderate NPDR

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

PRP

Procedure

Single session prophylactic early Pan-retinal Photocoagulation

Primary outcomes

  1. BCVA

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 16, 2022
Registry last updated
Sep 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.