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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Procedure: 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 Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 110-744
    • Department of Ophthalmology, Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Inclusion Criteria for epiretinal membrane group:

• Non-diabetic patients with an epiretinal membrane who were scheduled for vitrectomy
• No ocular or systemic disease other than epiretinal membrane

Inclusion Criteria for healthy group:

• No diabetes
• No ocular disease other than cataract

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ciliary body thickness	ciliary body thickness was determined using ultrasound biomicroscopy	up to four months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
central macular thickness	central macular thickness was determined using optical coherence tomography	up to four months after surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Ministry of Health & Welfare, Korea
• Investigators: Principal Investigator: Hyeong Gon Yu, M.D., Department of Ophthalmology, Seoul National University Hospital, Seoul, Republic of Korea

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): April 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: December 6, 2010
• First Submitted That Met QC Criteria: December 13, 2010
• First Posted (Estimate): December 14, 2010

Study Record Updates

• Last Update Posted (Estimate): December 14, 2010
• Last Update Submitted That Met QC Criteria: December 13, 2010
• Last Verified: December 1, 2010

More Information

Terms related to this study

• Keywords: Vitrectomy; Diabetic Macular Edema; Ciliary Body; Ultrasound Biomicroscopy
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema
• Other Study ID Numbers: SNUH_OT