Proliferative Diabetic Retinopathy Clinical Trial
Official title:
Macular Appearance After Diabetic Vitrectomy for Fibrovascular Proliferation -An Optical Coherence Tomography Study
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.
From June 2008 to December 2008 consecutive patients undergo pars plana vitrectomy for
diabetic fibrovascular proliferation were included in the 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 was done during surgery in every case. All cases included in
the study had attached retina postoperatively. Cases with rhegmatogenous detachment,
silicone oil infusion, or post-operative moderate to dense cataract were not included.
Surgical indications included progressive fibrovascular proliferation (FVP), and traction
retinal detachment. Postoperative standard 6 mm 6-line OCT (Stratus OCTTM optical coherence
tomography, Carl Zeiss Meditec, Inc., Dublin, CA) study centered on the macula and fundus
photography were carried out between 7 months to 15 months after surgery. All cases were
enrolled from the Department of Ophthalmology, National Taiwan University Hospital, Taipei,
Taiwan.
Data on patients' age, gender, systemic diseases, study eye, types and duration of diabetes
mellitus, intraoperative diagnosis, and additional surgical procedures such as cryotherapy,
scleral buckling [segmental sponge or 360º encircling buckle (Gore-Tex®,
polytetrafluoroethylene, W. L. Gore & Associates, Inc., Flagstaff, AZ)], or internal gas
(C3F8 or SF6) are recorded. Further data about OCT findings, best-corrected visual acuity at
the time of OCT images, and the duration of post-operative follow-up also are compiled.
Different morphological appearances of the macula detected by OCT are categorized. These
changes are compared between the two surgical subgroups. Correlations of the morphological
changes with postoperative visual outcome are conducted.
For the purpose of OCT categorization, measured thickness of more than 300um in the central
foveal area and more than 400um in the surrounding macular area in at least 3 examination
lines with or without intraretinal cystic spaces or epiretinal membrane is defined as
increase of macular thickness. Visible cystic spaces in and immediate adjacent to the fovea
is categorized as foveal cysts. The presence of clear optical empty space between pigment
epithelium and neurosensory retina are defined foveal detachment.
Statistical analysis In the first step of the statistical analyses, Chi-square test (or
Fisher exact test, if n<5) and Kruskal-Wallis test, followed by the Mann-Whitney U test were
used to analyze each variant individually for univariate analysis. In the second step,
multivariate regression models were used for elucidating the independent influence of each
morphological change on postoperative visual outcome. Levels of statistical significance
were set at P<0.05.
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