NCT01259609

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2010

Completed
Last Updated

December 14, 2010

Status Verified

December 1, 2010

Enrollment Period

1.6 years

First QC Date

December 6, 2010

Last Update Submit

December 13, 2010

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular EdemaCiliary BodyUltrasound BiomicroscopyVitrectomy

Outcome Measures

Primary Outcomes (1)

  • ciliary body thickness

    ciliary body thickness was determined using ultrasound biomicroscopy

    up to four months after surgery

Secondary Outcomes (1)

  • central macular thickness

    up to four months after surgery

Study Arms (3)

Diabetic Macular Edema Group

EXPERIMENTAL
Procedure: Pars Plana Vitrectomy

Epiretinal Membrane Group

ACTIVE COMPARATOR
Procedure: Pars Plana Vitrectomy

Healthy Control

NO INTERVENTION

Interventions

Pars Plana VitrectomyPROCEDURE

25-gauge three-port pars plana vitrectomy

Diabetic Macular Edema GroupEpiretinal Membrane Group

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Non-diabetic patients with an epiretinal membrane who were scheduled for vitrectomy
  • No ocular or systemic disease other than epiretinal membrane
  • No diabetes
  • No ocular disease other than cataract

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Study Officials

  • Hyeong Gon Yu, M.D.

    Department of Ophthalmology, Seoul National University Hospital, Seoul, Republic of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 6, 2010

First Posted

December 14, 2010

Study Start

September 1, 2008

Primary Completion

April 1, 2010

Study Completion

May 1, 2010

Last Updated

December 14, 2010

Record last verified: 2010-12

Locations

KR(1)