Macular Appearance After Diabetic Vitrectomy

NCT00737022 | Completed DMC

• 1 other identifier: 200805056R
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Vitrectomy is one of the major treatment methods for complications of diabetic retinopathy. As surgical techniques and instruments improve, high anatomical success may be achieved; however, functional results are less favorable. Despite attached retina, postoperative visual function may be affected by various macular and disc abnormalities. Major changes include optic atrophy, atrophic retina, poor macular perfusion, and structural alternations of the macula. Funduscopy, fluorescein angiography, and, more recently, optical coherence tomography (OCT) can be used to detect and document these alterations. Although fluorescein angiography is valuable in the assessment of various macular lesions as well as retinal vascular abnormalities, its usefulness in evaluating macular changes is limited in eyes that have undergone diabetic vitrectomy. The quality of the images may be compromised by mild diffuse hyperfluorescence in the posterior pole in middle and late phase angiography, which obscures capillary detail and subtle macular changes. Furthermore, quantification of changes may not be possible. Recently, optical coherence tomography has become very useful for the detection of vitreomacular abnormalities. The examination is noninvasive, can qualify the changes and detect subtle abnormalities not evident with other imaging studies. In this study, OCT was applied to investigate how common macular structure abnormalities are present after surgery for complications of diabetic retinopathy, and how they may affect visual prognosis.

Conditions

Proliferative Diabetic Retinopathy; Vitrectomy

Keywords

Diabetic vitrectomy; Epiretinal membrane (ERM); Macular appearance; Optical coherence tomography (OCT); Visual function

Outcome Measures

Primary Outcomes (1)

• Macular appearance

  Six months

Secondary Outcomes (1)

• Post-operation best-corrected visual acuity

  Six months

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Proliferative diabetic retinopathy

You may qualify if:

• From June 2008 to December 2008 consecutive patients undergo pars plana vitrectomy for diabetic fibrovascular proliferation are included in our study.
• All cases have fibrovascular proliferation with vitreo-retinal adhesions in 3 or more sites but not extending beyond equator in more than one quadrant.
• Complete removal of the visible posterior preretinal membrane must be done during surgery in every case.
• All cases are included in the study have attached retina postoperatively.

You may not qualify if:

• Cases with rhegmatogenous detachment, silicone oil infusion, or post-operative moderate to dense cataract are excluded.
• Patients are unable to follow-up regularly are not included.
• Patient refuses to join our study.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Department of Ophthalmology, National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Epiretinal Membrane

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Chung-May Yang, MD

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 18, 2008
• Study Start: May 1, 2005
• Primary Completion: July 1, 2006
• Study Completion: December 1, 2006
• Last Updated: August 18, 2008

Record last verified: 2006-07

Locations

TW (1)