An observational study in Development of Ptosis After Vitreo-retinal Surgery, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-20.
Sponsored by University of California, San Francisco · Observational
The purpose of this study to is to determine the incidence of post-operative ptosis in patients undergoing vitreoretinal surgery. An additional purpose is to identify pre-operative and intra-operative factors which correlate to the development of post-operative ptosis in vitreoretinal surgery cases.
This study will evaluate patients who will undergo vitreoretinal surgery at UCSF Medical Center and San Francisco General Hospital. After informed consent has been obtained, the measurement of eyelid parameters such as levator function, palpebral fissure height, upper eyelid crease height, MRD1 and MRD2 will be collected at pre-operative and post-operative follow up visits. External eye photographs taken at each visit will be evaluated by a masked reader who will calculate the eyelid parameters. Dermographic data and intraoperative factors such as operative time and type of procedure will be collected. For statistical analysis, Repeated ANOVA, Paired t-test, Wilcoxon signed rank test, Chi-square test and Pearson's correlation analysis will be calculated with SPSS software.
676 studies on the registry are indexed under Prolapse; 79 are open to participants now.
This study's enrollment of 50 is below the median of 126 across 222 observational studies indexed under Prolapse.
Browse Prolapse studies →University of California, San Francisco is the lead sponsor of 2,133 studies on the registry; 376 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patient who undergo vitreoretinal surgery at the University of California, San Francisco, and San Francisco General Hospital.
Exclusion Criteria:
Reduction of levator function
Difference between levator function at baseline and 6 months after surgery
Time frame: Baseline to 6 months
Operative time
Record of operative surgical time in each type of operation
Time frame: At operation
Change of palpebral fissure height, MRD1 and MRD2
Difference in palpebral fissure height, MRD1 and MRD2 between baseline and each post-operative visit.
Time frame: Baseline to 6 months
Incidence of ptosis
Incidence of clinically significant ptosis, defined as upper eyelid drooping of more than 2 mm.
Time frame: baseline to 6 months
This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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University of California, San Francisco