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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01752478

Enrollment

Registered

2012-12-19

Start date

2013-01-31

Completion date

2016-05-31

Last updated

2016-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Development of Ptosis After Vitreo-retinal Surgery

Keywords

ptosis, retina surgery, droopy eye lid

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Operative time	At operation	Record of operative surgical time in each type of operation
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.
Incidence of ptosis	baseline to 6 months	Incidence of clinically significant ptosis, defined as upper eyelid drooping of more than 2 mm.

Countries

United States

Outcome results