Loss to Follow-up in PDR Patients

Completed

• Conditions: Diabetic Retinopathy

• Registration Number: NCT04018326
• Lead Sponsor: Assiut University

Brief Summary

This study determined the clinical impact and causes of loss to follow-up (LTFU) from the patients' perspective in individuals with proliferative diabetic retinopathy (PDR) who received panretinal photocoagulation (PRP) and/or intravitreal injections (IVIs) of anti-vascular endothelial growth factor (VEGF).

This prospective cohort study included 467 patients with PDR who received PRP and/or IVIs of anti-VEGF between May 2013 and June 2018. LTFU was defined as missing any follow-up visit for any interval exceeding 6 months, provided that patients eventually resumed care. Main outcome measures include rates and causes of LTFU.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05-01
• Primary Completion: 2018-06-01
• Study Completion: 2018-12-25
• Status Verified: 2019-07
• Study First Submitted: 2019-07-09
• Study First Submitted QC: 2019-07-10
• Last Update Submitted: 2019-07-10
• Study First Posted: 2019-07-12
• Last Update Posted: 2019-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 467

Inclusion Criteria

• included treatment-naïve patients who had developed PDR in one eye with a best corrected visual acuity (BCVA) ranging from 20/22 to 20/69, as determined by the Snellen equivalent. Patients were allocated to receive PRP, IVIs of anti-VEGF, or a combination of both procedures.

Exclusion Criteria

1. patients receiving follow-up ophthalmic care for their PDR with or without interventions at any other medical care provider during the observation period, as declared by the patients at any follow up visit.
2. patients LTFU who did not resume follow-up until the end of the observation period.
3. patients needing PPV at first presentation or having additional retinal pathology. 4) patients receiving their treatment procedure during December 2017 or having vitreous hemorrhage that failed to clear up by June 2018 but still ineligible candidates for PPV.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Final BCVA	"through study completion, an average of 1 year",	logMAR BCVA at final follow up (Snellen equivalent)
Final UCVA	"through study completion, an average of 1 year",	Final logMAR UCVA (Snellen equivalent)