Compliance to Ophthalmic Follow-up Examinations and Surgical Outcome for Proliferative Diabetic Retinopathy

Completed

• Conditions: Proliferative Diabetic Retinopathy
• Interventions: Procedure: Vitrectomy

• Registration Number: NCT01307072
• Lead Sponsor: Kyorin University

Brief Summary

The relationship between the surgical outcome of vitreous surgery for proliferative diabetic retinopathy and the compliance to ophthalmic follow-up examinations was evaluated.

Detailed Description

The medical records of 94 patients that had undergone vitreous surgery for proliferative diabetic retinopathy (PDR) and were followed for at least 6 months were reviewed. The subjects were divided into three groups; the never-treated group consisting of patients who had no previous ophthalmic examination until the first visit when vitreous surgery was prescribed; the non-compliant group consisting of patients with a history of missing ophthalmic examination over a one year period, and the compliant group consisting of patients who had ophthalmic examinations at least once a year. The evaluations included age, gender, plasma level of glycosylated hemoglobin (HbA1c) at the preoperative examination, presence of preoperative panretinal photocoagulation, preoperative best-corrected visual acuity (BCVA), postoperative BCVA at the final examination, status of the PDR, the numbers of vitreous surgeries, and presence of pre- and postoperative neovascular glaucoma.

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2009-08
• Study Completion: 2010-04
• Study First Submitted: 2011-03-01
• Study First Submitted QC: 2011-03-01
• Study First Posted: 2011-03-02
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-31
• Last Update Posted: 2012-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• One hundred and twenty-eight eyes of 94 patients that had undergone vitreous surgery for proliferative diabetic retinopathy.
• Type 2 diabetes.

Exclusion Criteria

• The patients were not followed more than 6 months.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Never-treated group	Vitrectomy	The patients who had no previous ophthalmic examination until the first visit when vitreous surgery was prescribed
The non-compliant group	Vitrectomy	The patients with a history of missing ophthalmic examination over a one year period
The compliant group	Vitrectomy	The patients who had ophthalmic examinations at least once a year

Primary Outcome Measures

Name	Time	Method
Preoperative status	Preoperative period	Best-corrected visual acuity (BCVA),

Secondary Outcome Measures

Name	Time	Method
Postoperative status	up to 1 year	Presence of neovascular glaucoma.

Trial Locations

Locations (1)

Kyorin Eye Center; 🇯🇵 Mitaka, Tokyo, Japan