Changes in Ciliary Body Thickness in Patients With Diabetic Macular Edema After Vitrectomy

Not Applicable

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Procedure: Pars Plana Vitrectomy

• Registration Number: NCT01259609
• Lead Sponsor: Seoul National University Hospital

Brief Summary

The purpose of this study is to determine whether ciliary body thickness increased in the presence of diabetic macular edema and whether it changed after pars plana vitrectomy.

Detailed Description

A diabetic macular edema group consisted of diabetic patients who underwent PPV for diffuse diabetic macular edema. A epiretinal membrane group, a surgical control group, consisted of non-diabetic patients with epiretinal membrane who underwent pars plana vitrectomy. A healthy control was also included for the comparison of preoperative ciliary body thickness. Ciliary body thickness was measured using ultrasound biomicroscopy, and central macular thickness was determined using optical coherence tomography. The visual outcome, ciliary body thickness, and central macular thickness were compared between groups before and 1, 2, and 4 months after pars plana vitrectomy and the correlations between the central macular thickness and ciliary body thickness and best corrected visual acuity were determined.

Study Timeline

• Study Start: 2008-09
• Primary Completion: 2010-04
• Study Completion: 2010-05
• Status Verified: 2010-12
• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-13
• Last Update Submitted: 2010-12-13
• Study First Posted: 2010-12-14
• Last Update Posted: 2010-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diabetic Macular Edema Group	Pars Plana Vitrectomy	-
Epiretinal Membrane Group	Pars Plana Vitrectomy	-

Primary Outcome Measures

Name	Time	Method
ciliary body thickness	up to four months after surgery	ciliary body thickness was determined using ultrasound biomicroscopy

Secondary Outcome Measures

Name	Time	Method
central macular thickness	up to four months after surgery	central macular thickness was determined using optical coherence tomography

Trial Locations

Locations (1)

Department of Ophthalmology, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of