NCT04720586

Brief Summary

lower eyelid involutional entropion and dermatochalasis are common associated problems. combined approaches give good results.

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
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

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

August 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 18, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

January 28, 2021

Status Verified

January 1, 2021

Enrollment Period

2 years

First QC Date

January 18, 2021

Last Update Submit

January 26, 2021

Conditions

Eyelid Diseases

Keywords

entropionblepharoplasty

Outcome Measures

Primary Outcomes (1)

  • Global Aesthetic Improvement Scale

    calculate scale score (1-5); score 1 is exceptional improvement , score 5 is worsened patient

    12 months

Study Arms (2)

triple procedure

EXPERIMENTAL

lower eyelid retractors plication , transcutaneous blepharoplasty and wedge resection

Procedure: lower eyelid blepharoplasty , retractor plication and wedge resectionProcedure: lower eyelid blepharoplasty and retractor plication

combined procedure

ACTIVE COMPARATOR

lower eyelid retractors plication and transcutaneous blepharoplasty

Procedure: lower eyelid blepharoplasty , retractor plication and wedge resectionProcedure: lower eyelid blepharoplasty and retractor plication

Interventions

lower eyelid blepharoplasty , retractor plication and wedge resectionPROCEDURE

combined lower eyelid blepharoplasty , retractor plication and wedge resection

combined proceduretriple procedure
lower eyelid blepharoplasty and retractor plicationPROCEDURE

combined lower eyelid blepharoplasty and retractor plication procedures

combined proceduretriple procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Lower eyelid involutional entropion
  • dermatochalasis

You may not qualify if:

  • Other eyelid disease,
  • Other causes of entropion
  • 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 DiseasesEntropion

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Tarek R Elahamky, MD

    Benaha university faculty of medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tarek R Elhamaky, MD

CONTACT

+971503207889dr_thamakyy@yahoo.com

Treak R Elhamaky, MD

CONTACT

+971503207889dr_thamakyy@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

January 18, 2021

First Posted

January 22, 2021

Study Start

August 1, 2020

Primary Completion

August 1, 2022

Study Completion

August 31, 2022

Last Updated

January 28, 2021

Record last verified: 2021-01

Locations

AE(1)