Proliferative Diabetic Retinopathy Clinical Trial
Official title:
Macular Appearance After Diabetic Vitrectomy for Fibrovascular Proliferation -An Optical Coherence Tomography Study
Verified date | July 2006 |
Source | National Taiwan University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Taiwan: Department of Health |
Study type | Observational |
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.
Status | Completed |
Enrollment | 108 |
Est. completion date | December 2006 |
Est. primary completion date | July 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years to 85 Years |
Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - 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. |
Observational Model: Cohort, Time Perspective: Retrospective
Country | Name | City | State |
---|---|---|---|
Taiwan | Department of Ophthalmology, National Taiwan University Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
National Taiwan University Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Macular appearance | Six months | No | |
Secondary | Post-operation best-corrected visual acuity | Six months | No |
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