NCT05854420

Brief Summary

This study aims to assess the combination of anterior lamellar recession (ALR) with blepharoplasty, suprasternal fixation, and internal eyelash bulb extirpation of aberrant lashes posteriorly located in patients with any grade of upper eyelid trachomatous cicatricial entropion

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 11, 2023

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

2.8 years

First QC Date

May 3, 2023

Last Update Submit

May 10, 2023

Conditions

Outcome Measures

Primary Outcomes (4)

  • Success rate

    The cases will be considered succeed if there is no recurrence of the entropion

    3 months post operative

  • Success rate

    The cases will be considered succeed if there is no recurrence of the entropion

    6 months post operative

  • Success rate

    The cases will be considered succeed if there is no recurrence of the entropion

    9 months post operative

  • Success rate

    The cases will be considered succeed if there is no recurrence of the entropion

    12 months post operative

Study Arms (1)

Modified anterior Lamellar Recession

EXPERIMENTAL

All patients in this arm underwent a combination of ALR, blepharoplasty, suprasternal fixation, and cauterization or internal bulb extirpation of posteriorly located lashes.

Procedure: Modified anterior Lamellar Recession

Interventions

ALR is one of the procedures used to treat cicatricial entropion and trichiasis. Few studies present the effect of modifications to this procedure in trachomatous entropion and trichiasis. Because trachoma is common in our country, there is a probability that the number of surgeries for TT will rise.

Modified anterior Lamellar Recession

Eligibility Criteria

Age45 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All patients presented with upper lid trachomatous cicatricial entropion associated with rubbing lashes.
  • Patients having a history of argon laser ablation, electrolysis, epilation, or past unsuccessful surgery were also included

You may not qualify if:

  • Patients with a follow-up period of fewer than 12 months.
  • Patients with very severe UCE and required posterior lamellar grafts.
  • Patients with etiology other than trachoma.
  • Patients with dysplastic lashes without entropion were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ehab tharwat

Damietta, New Damietta, 34517, Egypt

Location

MeSH Terms

Conditions

Entropion

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 3, 2023

First Posted

May 11, 2023

Study Start

May 1, 2018

Primary Completion

March 1, 2021

Study Completion

March 15, 2021

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations