Functional Changes After Upper Blepharoplasty
Sponsor
Benha University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04201925
Collaborator
(none)
50
1
29.9
1.7
Study Details
Study Description
Brief Summary
Upper blepharoplasty is a common eyelid procedure. It associated with visual, cosmetic and functional changes .Investigator will evaluate outcome of this procedure.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
baseline and postoperative 1,3,6 and 12 months full ophthalmic examination was done.
Procedure is upper blepharoplasty.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Objective and Subjective Functional Outcomes Following Upper Blepharoplasty
Actual Study Start Date
:
Jan 1, 2019
Anticipated Primary Completion Date
:
Jun 1, 2021
Anticipated Study Completion Date
:
Jun 30, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| blepharoplasty Patients will undergo blepharoplasty surgery |
Procedure: upper blepharoplasty
excision of excess eyelid skin with or without strip of orbicularis muscle ; with or without upper orbital fat
|
Outcome Measures
Primary Outcome Measures
- visual field changes [6 months]
Post operative visual field changes in form of change in visual field sensitivity decibel (dB)using Humphrey Field Analyzer( HFA) II-i (Carl Zeiss Meditec ,Jena, Germany)
Secondary Outcome Measures
- corneal topographic changes [6 months]
Postoperative topographic changes of the cornea in form of central keratoconus index using Pentacam HR (Oculus GmbH, Wetzlar, Germany).
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
• upper eyelid Dermatochalasis
Exclusion Criteria:
-
Eyelid diseases
-
previous eyelid surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | INMC | Abu Dhabi | United Arab Emirates | 46266 |
Sponsors and Collaborators
- Benha University
Investigators
- Principal Investigator: TAREK R ELAHAMKY, MD, Benha university faculty of medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Tarek Roshdy mohamed Mahgoub ELhamaky,
Lecturer of ophthalmology,
Benha University
ClinicalTrials.gov Identifier:
NCT04201925
Other Study ID Numbers:
- hamaky3
First Posted:
Dec 17, 2019
Last Update Posted:
Jan 27, 2021
Last Verified:
Jan 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tarek Roshdy mohamed Mahgoub ELhamaky,
Lecturer of ophthalmology,
Benha University
Additional relevant MeSH terms: