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

NCT ID: NCT01307072

Last Updated: 2012-08-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

94 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-04-30

Brief Summary

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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

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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.

Conditions

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Proliferative Diabetic Retinopathy

Keywords

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periodic examinations, compliance

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Never-treated group

The patients who had no previous ophthalmic examination until the first visit when vitreous surgery was prescribed

Vitrectomy

Intervention Type PROCEDURE

Vitrectomy. Diabetic retinopathy

The non-compliant group

The patients with a history of missing ophthalmic examination over a one year period

Vitrectomy

Intervention Type PROCEDURE

Vitrectomy. Diabetic retinopathy

The compliant group

The patients who had ophthalmic examinations at least once a year

Vitrectomy

Intervention Type PROCEDURE

Vitrectomy. Diabetic retinopathy

Interventions

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Vitrectomy

Vitrectomy. Diabetic retinopathy

Intervention Type PROCEDURE

Other Intervention Names

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Compliance of follow-up

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyorin University

OTHER

Sponsor Role lead

Responsible Party

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Makoto Inoue

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Makoto Inoue, MD

Role: PRINCIPAL_INVESTIGATOR

Kyorin Eye Center

Locations

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Kyorin Eye Center

Mitaka, Tokyo, Japan

Site Status

Countries

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Japan

Other Identifiers

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Kyorineye003

Identifier Type: -

Identifier Source: org_study_id