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OpenTrials
Completed

NCT Number: NCT01259609

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology, Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pars plana vitrectomy

Procedure

25-gauge three-port pars plana vitrectomy

Primary outcomes

  1. ciliary body thickness

    Time frame: up to four months after surgery

    ciliary body thickness was determined using ultrasound biomicroscopy

Secondary outcomes

  1. central macular thickness

    Time frame: up to four months after surgery

    central macular thickness was determined using optical coherence tomography

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Ministry of Health & Welfare, Korea

Registry information

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Dec 14, 2010
Registry last updated
Dec 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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