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

Development of Ptosis After Vitreo-retinal Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752478
• Other study ID #: UCSF-Retina
• Status: Completed
• Phase: N/A
• First received: December 14, 2012
• Last updated: May 18, 2016
• Start date: January 2013
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Development of Ptosis After Vitreo-retinal Surgery
• Prolapse

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (7)

Bernardino CR, Rubin PA. Ptosis after cataract surgery. Semin Ophthalmol. 2002 Sep-Dec;17(3-4):144-8. Review. — View Citation

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. — View Citation

Edmonson BC, Wulc AE. Ptosis evaluation and management. Otolaryngol Clin North Am. 2005 Oct;38(5):921-46. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Ropo A, Ruusuvaara P, Nikki P. Ptosis following periocular or general anaesthesia in cataract surgery. Acta Ophthalmol (Copenh). 1992 Apr;70(2):262-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of levator function	Difference between levator function at baseline and 6 months after surgery	Baseline to 6 months	No
Secondary	Operative time	Record of operative surgical time in each type of operation	At operation	No
Secondary	Change of palpebral fissure height, MRD1 and MRD2	Difference in palpebral fissure height, MRD1 and MRD2 between baseline and each post-operative visit.	Baseline to 6 months	No
Secondary	Incidence of ptosis	Incidence of clinically significant ptosis, defined as upper eyelid drooping of more than 2 mm.	baseline to 6 months	No