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

Diabetic Macular Edema Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01259609
• Other study ID #: SNUH_OT
• Status: Completed
• Phase: N/A
• First received: December 6, 2010
• Last updated: December 13, 2010
• Start date: September 2008
• Est. completion date: May 2010

Study information

• Verified date: December 2010
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 2010
• Est. primary completion date: April 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Procedure:
• Pars Plana Vitrectomy
25-gauge three-port pars plana vitrectomy

Locations

Country	Name	City	State
Korea, Republic of	Department of Ophthalmology, Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ministry of Health & Welfare, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ciliary body thickness	ciliary body thickness was determined using ultrasound biomicroscopy	up to four months after surgery	No
Secondary	central macular thickness	central macular thickness was determined using optical coherence tomography	up to four months after surgery	No