Preoperative and Intraoperative Factors Related to the Development of Ptosis After Retinal Surgery

Completed

• Conditions: Development of Ptosis After Vitreo-retinal Surgery

• Registration Number: NCT01752478
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2012-12-14
• Study First Submitted QC: 2012-12-14
• Study First Posted: 2012-12-19
• Study Start: 2013-01
• Status Verified: 2016-05
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-18
• Last Update Posted: 2016-05-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients who have vitreoretinal surgery from January 2013

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Exclusion Criteria

• Minors, younger than age 18.
• Patients who have pre-existing ptosis at baseline in the operative eye.
• Patients who are not able to cooperate with eyelid ptosis measurements

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of levator function	Baseline to 6 months	Difference between levator function at baseline and 6 months after surgery

Secondary Outcome Measures

Name	Time	Method
Incidence of ptosis	baseline to 6 months	Incidence of clinically significant ptosis, defined as upper eyelid drooping of more than 2 mm.
Change of palpebral fissure height, MRD1 and MRD2	Baseline to 6 months	Difference in palpebral fissure height, MRD1 and MRD2 between baseline and each post-operative visit.
Operative time	At operation	Record of operative surgical time in each type of operation

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States