Prophylactic PRP in Moderate NPDR

NCT05543564 | Completed

• 1 other identifier: 17300819
• Study Type: observational
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Eye Diseases; Diabetes; Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

• BCVA

  3 months

Interventions

PRP PROCEDURE

Single session prophylactic early Pan-retinal Photocoagulation

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate NPDR at high risk

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University

Asyut, 71515, Egypt

Location

MeSH Terms

Conditions

Eye Diseases; Diabetes Mellitus; Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Retinal Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 14, 2022
• First Posted: September 16, 2022
• Study Start: February 1, 2019
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: September 16, 2022

Record last verified: 2022-09

Locations

EG (1)