Development of Ptosis After Vitreo-retinal SurgeryNCT01752478
Preoperative and Intraoperative Factors Related to the Development of Ptosis After Retinal Surgery
An observational study of Development of Ptosis After Vitreo-retinal Surgery, run by University of California, San Francisco at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Development of Ptosis After Vitreo-retinal Surgery
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to May 2016
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient who undergo vitreoretinal surgery at the University of California, San Francisco, and San Francisco General Hospital.
Who may be able to join
- Patients who have vitreoretinal surgery from January 2013
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
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.
Read the 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.
- Keywords
- ptosis, retina surgery, droopy eye lid
- Medical subject headings
- Blepharoptosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of levator function
Difference between levator function at baseline and 6 months after surgery
Measured: Baseline to 6 months
Secondary outcomes (3)
Operative time
Record of operative surgical time in each type of operation
Measured: At operation
Change of palpebral fissure height, MRD1 and MRD2
Difference in palpebral fissure height, MRD1 and MRD2 between baseline and each post-operative visit.
Measured: Baseline to 6 months
Incidence of ptosis
Incidence of clinically significant ptosis, defined as upper eyelid drooping of more than 2 mm.
Measured: baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2012 (estimated)
- Study startJan 2013
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Development of Ptosis After Vitreo-retinal SurgeryStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jay M Stewart, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01752478
- Sponsor's protocol ID
- UCSF-Retina
- Status last verified
- May 2016
- First submitted
- 14 Dec 2012
- Last updated
- 20 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 16214567Bernardino 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.
PubMed 12759843Paris 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.
PubMed 1258958Kasbekar 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.
PubMed 21701526Ropo 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.
PubMed 1609577Donker 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.
PubMed 16310482Quintyn 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.
PubMed 12967812
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative and Intraoperative Factors Related to the Development of Ptosis After Retinal Surgery
- ClinicalTrials.gov ID
- NCT01752478
- Acronym / sponsor ID
- UCSF-Retina
- Keywords
- ptosis, retina surgery, droopy eye lid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 19 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who undergo vitreoretinal surgery at the University of California, San Francisco, and San Francisco General Hospital.
Key inclusion criteria (1 listed)
- Patients who have vitreoretinal surgery from January 2013
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Reduction of levator function
Time frame: Baseline to 6 months
Difference between levator function at baseline and 6 months after surgery
3 secondary outcomes
Operative time
Time frame: At operation
Change of palpebral fissure height, MRD1 and MRD2
Time frame: Baseline to 6 months
Incidence of ptosis
Time frame: baseline to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2016.
- Background: PubMed 16214567Edmonson 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.
- Background: PubMed 12759843Bernardino 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.
- Background: PubMed 1258958Paris 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.
- Background: PubMed 21701526Kasbekar 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.
- Background: PubMed 1609577Ropo 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.
- Background: PubMed 16310482Donker 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.
- Background: PubMed 12967812Quintyn 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jay M Stewart, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Development of Ptosis After Vitreo-retinal Surgery, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of levator function (time frame: Baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01752478, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2016.