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

May 18, 2016 updated by: University of California, San Francisco
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient who undergo vitreoretinal surgery at the University of California, San Francisco, and San Francisco General Hospital.

Description

Inclusion Criteria:

  • Patients who have vitreoretinal surgery from January 2013

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of levator function
Time Frame: Baseline to 6 months
Difference between levator function at baseline and 6 months after surgery
Baseline to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

December 14, 2012

First Submitted That Met QC Criteria

December 14, 2012

First Posted (ESTIMATE)

December 19, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 20, 2016

Last Update Submitted That Met QC Criteria

May 18, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCSF-Retina

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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