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

NCT ID: NCT01752478

Last Updated: 2016-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2016-05-31

Brief Summary

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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

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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.

Conditions

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Development of Ptosis After Vitreo-retinal Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jay M Stewart, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status

Countries

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United States

References

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Edmonson BC, Wulc AE. Ptosis evaluation and management. Otolaryngol Clin North Am. 2005 Oct;38(5):921-46. doi: 10.1016/j.otc.2005.08.012. No abstract available.

Reference Type BACKGROUND
PMID: 16214567 (View on PubMed)

Bernardino CR, Rubin PA. Ptosis after cataract surgery. Semin Ophthalmol. 2002 Sep-Dec;17(3-4):144-8. doi: 10.1076/soph.17.3.144.14782.

Reference Type BACKGROUND
PMID: 12759843 (View on PubMed)

Paris GL, Quickert MH. Disinsertion of the aponeurosis of the levator palpebrae superioris muscle after cataract extraction. Am J Ophthalmol. 1976 Mar;81(3):337-40. doi: 10.1016/0002-9394(76)90250-6.

Reference Type BACKGROUND
PMID: 1258958 (View on PubMed)

Kasbekar SA, Wong V, Young J, Stappler T, Durnian JM. Strabismus following retinal detachment repair: a comparison between scleral buckling and vitrectomy procedures. Eye (Lond). 2011 Sep;25(9):1202-6. doi: 10.1038/eye.2011.152. Epub 2011 Jun 24.

Reference Type BACKGROUND
PMID: 21701526 (View on PubMed)

Ropo A, Ruusuvaara P, Nikki P. Ptosis following periocular or general anaesthesia in cataract surgery. Acta Ophthalmol (Copenh). 1992 Apr;70(2):262-5. doi: 10.1111/j.1755-3768.1992.tb04134.x.

Reference Type BACKGROUND
PMID: 1609577 (View on PubMed)

Donker DL, Paridaens D, Mooy CM, van den Bosch WA. Blepharoptosis and upper eyelid swelling due to lipogranulomatous inflammation caused by silicone oil. Am J Ophthalmol. 2005 Nov;140(5):934-6. doi: 10.1016/j.ajo.2005.05.028.

Reference Type BACKGROUND
PMID: 16310482 (View on PubMed)

Quintyn JC, Genevois O, Ranty ML, Retout A. Silicone oil migration in the eyelid after vitrectomy for retinal detachment. Am J Ophthalmol. 2003 Sep;136(3):540-2. doi: 10.1016/s0002-9394(03)00385-4.

Reference Type BACKGROUND
PMID: 12967812 (View on PubMed)

Other Identifiers

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UCSF-Retina

Identifier Type: -

Identifier Source: org_study_id

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