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

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Pars Plana Vitrectomy
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetic Macular Edema focused on measuring Diabetic Macular Edema, Ciliary Body, Ultrasound Biomicroscopy, Vitrectomy

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Ophthalmology, Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Diabetic Macular Edema Group

Epiretinal Membrane Group

Healthy Control

Arm Description

Outcomes

Primary Outcome Measures

ciliary body thickness
ciliary body thickness was determined using ultrasound biomicroscopy

Secondary Outcome Measures

central macular thickness
central macular thickness was determined using optical coherence tomography

Full Information

First Posted
December 6, 2010
Last Updated
December 13, 2010
Sponsor
Seoul National University Hospital
Collaborators
Ministry of Health & Welfare, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT01259609
Brief Title
Changes in Ciliary Body Thickness in Patients With Diabetic Macular Edema After Vitrectomy
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Seoul National University Hospital
Collaborators
Ministry of Health & Welfare, Korea

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Diabetic Macular Edema, Ciliary Body, Ultrasound Biomicroscopy, Vitrectomy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diabetic Macular Edema Group
Arm Type
Experimental
Arm Title
Epiretinal Membrane Group
Arm Type
Active Comparator
Arm Title
Healthy Control
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Pars Plana Vitrectomy
Intervention Description
25-gauge three-port pars plana vitrectomy
Primary Outcome Measure Information:
Title
ciliary body thickness
Description
ciliary body thickness was determined using ultrasound biomicroscopy
Time Frame
up to four months after surgery
Secondary Outcome Measure Information:
Title
central macular thickness
Description
central macular thickness was determined using optical coherence tomography
Time Frame
up to four months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyeong Gon Yu, M.D.
Organizational Affiliation
Department of Ophthalmology, Seoul National University Hospital, Seoul, Republic of Korea
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of

12. IPD Sharing Statement

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

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