Proliferative Diabetic Retinopathy Clinical Trial
Official title:
Macular Hole in Proliferative Diabetic Retinopathy With Fibrovascular Proliferation
Macular hole in proliferative diabetic retinopathy with fibrovascular proliferation may have unique features. Internal limiting membrane peeling facilitates hole closure only in cases with shallow macular detachment. Final vision is associated with preoperative visual acuity and degree of macula elevation.
From January 2002 to December 2007 consecutive patients undergo pars plana vitrectomy for
diabetic fibrovascular proliferation and the medical and surgical records are reviewed.
Diabetic fibrovascular proliferation associated with macular hole that had undergone pars
plana vitrectomy with a minimum of 6 months of post-operative follow-up will be
retrospectively reviewed. Cases fulfilling the indication criteria will be selected for the
study All operations had been performed following the same principle and techniques.
Demographics and clinical findings of each case will be recorded including age, sex,
involved eye, duration of macular hole, intraoperative diagnosis, extent of vitreo-retinal
adhesion and detachment, morphology of macular hole, and relationship of macular hole to
posterior hyaloid and fibrovascular proliferation. Data regarding treatment of macular hole,
final opening or closure of macular hole, and duration of postoperative follow-up will also
be compiled. Results of ophthalmological examinations, including pre- and post-operation
best corrected visual acuity, intraocular pressure, and intravitreal tamponade material will
be recorded. Optical coherence tomography (OCT) findings will be categorized and recorded.
Retinal detachment severity will be classified as: no traction retinal detachment (TRD) or
TRD within arcade (grade 1); TRD outside arcade, but not to or beyond the equator (grade 2);
and RD extended to the periphery in at least 1 quadrant (grade 3). The degree of macular
elevation surrounding the macular hole will be classified into three grades according to
pre- or intra-operative observation: shallow: barely visible macular detachment with or
without fine retinal folds and with underlying choroidal patterns still identifiable through
the detached retina; moderate: obvious detachment with folds and loss of visualization of
underlying choroidal patterns; and high: convex shaped or dome shaped detachment with wavy
configuration in the macular area. Extent of fibrovascular proliferation will be separated
into 3 grades: grade 1: focal adhesions only; grade 2: broad adhesion at more than 1 site or
vitreous-retinal adhesion at disc, macula or arcade; and grade 3: vitreous-retinal
attachment extending to the periphery.
Statistical Analysis To examine the significance of various clinical findings in relation to
final macular hole closure rate, statistical analysis of the data is performed with
chi-squared test or Fisher's exact test. To further verify the clinical characteristics and
treatments that affecting macular hole closure, multivariate logistic regression analysis is
performed to determine the significance of the following factors: age, sex, operation eye,
duration of macular hole, RD extent, submacular fluid level, extent of fibrovascular
proliferation, macular hole shape, and intravitreal tamponade materials. An association of
post-operative best-corrected visual acuity with other study variables is assessed by
multiple lineal regression analysis, using backward Wald's criteria, taking post-operation
best-correted visual acuity as the dependent variable. All of the statistical analyses are
performed using STATA 8.2 software (StataCorp LP, College Station, Texas, USA). A P value <
0.05 is considered statistically significant.
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Observational Model: Cohort, Time Perspective: Retrospective
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