Loss to Follow-up in PDR Patients

Diabetic Retinopathy Clinical Trial

Official title:

Causes and Clinical Impact of Loss to Follow-up in Patients With Proliferative Diabetic Retinopathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04018326
• Other study ID #: 17300291
• Status: Completed
• Start date: May 1, 2013
• Est. completion date: December 25, 2018

Study information

• Verified date: July 2019
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 467
• Est. completion date: December 25, 2018
• Est. primary completion date: June 1, 2018
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Final BCVA	logMAR BCVA at final follow up (Snellen equivalent)	"through study completion, an average of 1 year",
Primary	Final UCVA	Final logMAR UCVA (Snellen equivalent)	"through study completion, an average of 1 year",