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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01259609

Collaborator

Ministry of Health & Welfare, Korea (Other)

Enrollment

Location

Arms

19.9

Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetic Macular Edema	Procedure: Pars Plana Vitrectomy	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

82 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

May 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Diabetic Macular Edema Group	Procedure: Pars Plana Vitrectomy 25-gauge three-port pars plana vitrectomy
Active Comparator: Epiretinal Membrane Group	Procedure: Pars Plana Vitrectomy 25-gauge three-port pars plana vitrectomy
No Intervention: Healthy Control

Arm

Intervention/Treatment

Experimental: Diabetic Macular Edema Group

Procedure: Pars Plana Vitrectomy

25-gauge three-port pars plana vitrectomy

Active Comparator: Epiretinal Membrane Group

Procedure: Pars Plana Vitrectomy

25-gauge three-port pars plana vitrectomy

No Intervention: Healthy Control

Outcome Measures

Primary Outcome Measures

ciliary body thickness [up to four months after surgery]
ciliary body thickness was determined using ultrasound biomicroscopy

Secondary Outcome Measures

central macular thickness [up to four months after surgery]
central macular thickness was determined using optical coherence tomography

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria for diabetic macular edema group:

Diabetic macular edema with preoperative central macular thickness > 300 μm on optical coherence tomography
Macular edema that was not associated with an epiretinal membrane or traction membrane
No combined traction retinal detachment or vitreous hemorrhage
No signs of ocular inflammatory disease on preoperative examination
Phakic eye
An axial length between 22.0 mm and 25.0 mm

Exclusion Criteria for diabetic macular edema group:

Patients with uveitis, inflammatory connective tissue disorders or a history of previous ocular surgery
Long-term application of topical medication, a history of intravitreal steroid or anti-VEGF injection within 3 months before vitrectomy