Status:

COMPLETED

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

Lead Sponsor:

Seoul National University Hospital

Collaborating Sponsors:

Ministry of Health & Welfare, Korea

Conditions:

Diabetic Macular Edema

Eligibility:

All Genders

20-70 years

Phase:

NA

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 pat...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    September 1 2008

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 1 2010

    Estimated Enrollment :

    82 Patients enrolled

    Trial Details

    Trial ID

    NCT01259609

    Start Date

    September 1 2008

    End Date

    May 1 2010

    Last Update

    December 14 2010

    Active Locations (1)

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    1

    Department of Ophthalmology, Seoul National University Hospital

    Seoul, South Korea, 110-744