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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01259609
Enrollment
82
Registered
2010-12-14
Start date
2008-09-30
Completion date
2010-05-31
Last updated
2010-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular Edema, Ciliary Body, Ultrasound Biomicroscopy, Vitrectomy

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.

Interventions

PROCEDUREPars Plana Vitrectomy

25-gauge three-port pars plana vitrectomy

Sponsors

Ministry of Health & Welfare, Korea
CollaboratorOTHER_GOV
Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
ciliary body thicknessup to four months after surgeryciliary body thickness was determined using ultrasound biomicroscopy

Secondary

MeasureTime frameDescription
central macular thicknessup to four months after surgerycentral macular thickness was determined using optical coherence tomography

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026