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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health & Welfare, Korea
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01259609
First received: December 6, 2010
Last updated: December 13, 2010
Last verified: December 2010
History of Changes
  Purpose

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 Intervention
Diabetic Macular Edema
 Procedure: Pars Plana Vitrectomy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Resource links provided by NLM:

MedlinePlus related topics: Edema
U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • ciliary body thickness [ Time Frame: up to four months after surgery ] [ Designated as safety issue: No ]
    ciliary body thickness was determined using ultrasound biomicroscopy


Secondary Outcome Measures:
  • central macular thickness [ Time Frame: up to four months after surgery ] [ Designated as safety issue: No ]
    central macular thickness was determined using optical coherence tomography


Enrollment: 82
Study Start Date: September 2008
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259609

Locations
Korea, Republic of
Department of Ophthalmology, Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Ministry of Health & Welfare, Korea
Investigators
Principal Investigator: Hyeong Gon Yu, M.D. Department of Ophthalmology, Seoul National University Hospital, Seoul, Republic of Korea
  More Information

No publications provided

Responsible Party: Hyeong Gon Yu, Department of Ophthalmology, Seoul National University Hospital, Seoul, Korea
ClinicalTrials.gov Identifier: NCT01259609     History of Changes
Other Study ID Numbers: SNUH_OT
Study First Received: December 6, 2010
Last Updated: December 13, 2010
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
Diabetic Macular Edema
Ciliary Body
Ultrasound Biomicroscopy
Vitrectomy

Additional relevant MeSH terms:
Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
 Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on May 19, 2013