MedDataX Logo

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

NCT ID: NCT01259609

Last Updated: 2010-12-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2010-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetic Macular Edema

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Diabetic Macular Edema Ciliary Body Ultrasound Biomicroscopy Vitrectomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Diabetic Macular Edema Group

Group Type EXPERIMENTAL

Pars Plana Vitrectomy

Intervention Type PROCEDURE

25-gauge three-port pars plana vitrectomy

Epiretinal Membrane Group

Group Type ACTIVE_COMPARATOR

Pars Plana Vitrectomy

Intervention Type PROCEDURE

25-gauge three-port pars plana vitrectomy

Healthy Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pars Plana Vitrectomy

25-gauge three-port pars plana vitrectomy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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


* 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

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ministry of Health & Welfare, Korea

OTHER_GOV

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

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

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hyeong Gon Yu, M.D.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Ophthalmology, Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SNUH_OT

Identifier Type: -

Identifier Source: org_study_id