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CompletedNCT01259609Updated Dec 14, 2010

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

An interventional study of Pars Plana Vitrectomy in Diabetic Macular Edema, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2010-12-14.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
82
Allocation
Non-randomized
Ages
20 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Diabetic Macular Edema

Keywords

  • Diabetic Macular Edema
  • Ciliary Body
  • Ultrasound Biomicroscopy
  • Vitrectomy
03

In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

This study's enrollment of 82 is above the median of 50 across 619 interventional studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 70 Years
Sexes eligible
All
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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    Diabetic Macular Edema Group

    Procedure: Pars Plana Vitrectomy

  • Active comparator
    Epiretinal Membrane Group

    Procedure: Pars Plana Vitrectomy

  • No intervention
    Healthy Control

Interventions

  • ProcedurePars Plana Vitrectomy

    25-gauge three-port pars plana vitrectomy

06

What researchers measure

Primary outcomes

  1. ciliary body thickness

    ciliary body thickness was determined using ultrasound biomicroscopy

    Time frame: up to four months after surgery

Secondary outcomes

  1. central macular thickness

    central macular thickness was determined using optical coherence tomography

    Time frame: up to four months after surgery

07

Study locations

1 site
  • Department of Ophthalmology, Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01259609
Lead sponsor
Seoul National University Hospital
Collaborators
Ministry of Health & Welfare, Korea
First posted
Dec 14, 2010
Start date
Sep 2008
Primary completion
Apr 2010
Completion
May 2010
Last update
Dec 14, 2010

Study contacts

Hyeong Gon Yu, M.D.
principal investigator · Department of Ophthalmology, Seoul National University Hospital, Seoul, Republic of Korea

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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