Loss to Follow-up in PDR Patients

NCT04018326 | Completed

• 1 other identifier: 17300291
• Study Type: observational
• Target: 467
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Diabetic Retinopathy

Keywords

loss to follow-up; proliferative diabetic retinopathy; diabetic retinopathy; panretinal photocoagulation; intravitreal injections

Outcome Measures

Primary Outcomes (2)

• Final BCVA

  logMAR BCVA at final follow up (Snellen equivalent)

  "through study completion, an average of 1 year",

• Final UCVA

  Final logMAR UCVA (Snellen equivalent)

  "through study completion, an average of 1 year",

Study Arms (2)

Compliant patients

The compliant patient was defined as a patient who did not miss any follow-up visit until the end of the study period.

Loss to follow-up (LTFU)

LTFU was defined as missing any follow-up visit for any interval exceeding 6 months provided that patients eventually resumed care before the end of the study period (time zero was defined as the date of the missed follow-up visit).

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who had developed PDR in one eye. Patients were allocated to receive PRP, IVIs of anti-VEGF, or a combination of both procedures.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• patients LTFU who did not resume follow-up until the end of the observation period.
• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (1)

• Abdelmotaal H, Ibrahim W, Sharaf M, Abdelazeem K. Causes and Clinical Impact of Loss to Follow-Up in Patients with Proliferative Diabetic Retinopathy. J Ophthalmol. 2020 Feb 8;2020:7691724. doi: 10.1155/2020/7691724. eCollection 2020.

  PMID: 32089871 DERIVED

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Design

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

Study Record Dates

• First Submitted: July 9, 2019
• First Posted: July 12, 2019
• Study Start: May 1, 2013
• Primary Completion: June 1, 2018
• Study Completion: December 25, 2018
• Last Updated: July 12, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share