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Completed

NCT Number: NCT01752478

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.

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Key information

Conditions

Development of Ptosis After Vitreo-retinal Surgery Blepharoptosis Eye Diseases Eyelid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Reduction of levator function

    Time frame: Baseline to 6 months

    Difference between levator function at baseline and 6 months after surgery

Secondary outcomes

  1. Operative time

    Time frame: At operation

    Record of operative surgical time in each type of operation

  2. 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.

  3. Incidence of ptosis

    Time frame: baseline to 6 months

    Incidence of clinically significant ptosis, defined as upper eyelid drooping of more than 2 mm.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 19, 2012
Registry last updated
May 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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