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Loss to Follow-up in PDR Patients

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ClinicalTrials.gov Identifier: NCT04018326
Recruitment Status : Completed
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Information provided by (Responsible Party):
Khaled Abdelazeem, 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.


Condition or disease
Diabetic Retinopathy

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Study Type : Observational
Actual Enrollment : 467 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Causes and Clinical Impact of Loss to Follow-up in Patients With Proliferative Diabetic Retinopathy
Actual Study Start Date : May 1, 2013
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : December 25, 2018

Resource links provided by the National Library of Medicine


Group/Cohort
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).



Primary Outcome Measures :
  1. Final BCVA [ Time Frame: "through study completion, an average of 1 year", ]
    logMAR BCVA at final follow up (Snellen equivalent)

  2. Final UCVA [ Time Frame: "through study completion, an average of 1 year", ]
    Final logMAR UCVA (Snellen equivalent)



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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 Documents (Full-Text)

Documents provided by Khaled Abdelazeem, Assiut University:

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Responsible Party: Khaled Abdelazeem, Associate Professor of Ophthalmology, Assiut University
ClinicalTrials.gov Identifier: NCT04018326     History of Changes
Other Study ID Numbers: 17300291
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Khaled Abdelazeem, Assiut University:
loss to follow-up
proliferative diabetic retinopathy
diabetic retinopathy
panretinal photocoagulation
intravitreal injections

Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases