NCT04201925

Brief Summary

Upper blepharoplasty is a common eyelid procedure. It associated with visual, cosmetic and functional changes .Investigator will evaluate outcome of this procedure.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2019

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 17, 2019

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

2.4 years

First QC Date

November 24, 2019

Last Update Submit

January 26, 2021

Conditions

Eyelid Diseases

Keywords

blepharoplasty, visual field

Outcome Measures

Primary Outcomes (1)

  • visual field changes

    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)

    6 months

Secondary Outcomes (1)

  • corneal topographic changes

    6 months

Study Arms (1)

blepharoplasty

Patients will undergo blepharoplasty surgery

Procedure: upper blepharoplasty

Interventions

upper blepharoplastyPROCEDURE

excision of excess eyelid skin with or without strip of orbicularis muscle ; with or without upper orbital fat

blepharoplasty

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

50 patient with upper eyelid Dermatochalasis and will undergo upper blepharoblasty procedure.

You may qualify if:

  • upper eyelid Dermatochalasis

You may not qualify if:

  • Eyelid diseases
  • previous eyelid surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INMC

Abu Dhabi, 46266, United Arab Emirates

RECRUITING

MeSH Terms

Conditions

Eyelid Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • TAREK R ELAHAMKY, MD

    Benha university faculty of medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

TAREK R ELHAMAKY, MD

CONTACT

+971503207889dr_thamakyy@yahoo.com

TAREK ELHAMAKY

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of ophthalmology

Study Record Dates

First Submitted

November 24, 2019

First Posted

December 17, 2019

Study Start

January 1, 2019

Primary Completion

June 1, 2021

Study Completion

June 30, 2021

Last Updated

January 27, 2021

Record last verified: 2021-01

Locations

AE(1)