Trial record 4 of 4 for:    Open Studies | "Blepharoptosis"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01752478
First received: December 14, 2012
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition
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

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752478

Contacts
Contact: Jay M Stewart, MD (415) 476-1922 stewartj@vision.ucsf.edu

Locations
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         
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Jay M Stewart, MD University of California, San Francisco
  More Information

Publications:
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01752478     History of Changes
Other Study ID Numbers: UCSF-Retina
Study First Received: December 14, 2012
Last Updated: April 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
ptosis
retina surgery
droopy eye lid

Additional relevant MeSH terms:
Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on September 22, 2014