Preoperative and Intraoperative Factors Related to the Development of Ptosis After Retinal Surgery
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.
Development of Ptosis After Vitreo-retinal Surgery
|Study Type:||Observational [Patient Registry]|
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Target Follow-Up Duration:||6 Months|
|Official Title:||Preoperative and Intraoperative Factors Related to the Development of Ptosis After Retinal Surgery|
- Reduction of levator function [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]Difference between levator function at baseline and 6 months after surgery
- Operative time [ Time Frame: At operation ] [ Designated as safety issue: No ]Record of operative surgical time in each type of operation
- Change of palpebral fissure height, MRD1 and MRD2 [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]Difference in palpebral fissure height, MRD1 and MRD2 between baseline and each post-operative visit.
- Incidence of ptosis [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]Incidence of clinically significant ptosis, defined as upper eyelid drooping of more than 2 mm.
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||October 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752478
|Contact: Jay M Stewart, MD||(415) firstname.lastname@example.org|
|United States, California|
|University of California, San Francisco||Recruiting|
|San Francisco, California, United States, 94143|
|Contact: Jay M. Stewart, MD 415-476-1922|
|Contact: Pear Pongsachareonnont, MD (415) 527-6917|
|Sub-Investigator: Pear Pongsachareonnont, MD|
|Sub-Investigator: M. Reza Vagefi, MD|
|Principal Investigator:||Jay M Stewart, MD||University of California, San Francisco|