NCT04961021

Brief Summary

Patients with consecutive exotropia will be managed by medial rectus muscle advancement +/- resection or medial rectus muscle advancement +/- lateral rectus recession

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2020

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

August 3, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 14, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

January 26, 2022

Status Verified

January 1, 2022

Enrollment Period

1.2 years

First QC Date

July 9, 2021

Last Update Submit

January 24, 2022

Conditions

StrabismusConcomitant SquintDivergent Strabismus

Outcome Measures

Primary Outcomes (1)

  • Percentage of patients with satisfactory postoperative alignment

    Efficacy of each surgical procedure and its further effect using prism cover test to access postoperative alignment of the eye

    6 months

Study Arms (2)

Medial rectus advancement with resection

ACTIVE COMPARATOR

Surgery will be done to strengthen the medial rectus muscle with resection and anterior displacement again to the original insertion site 5 mm from limbus

Procedure: Strabismus surgery

Medial rectus advancement with lateral rectus recession

ACTIVE COMPARATOR

Surgery will be done to strengthen the medial rectus muscle with anterior displacement again to the original insertion site 4- 5 mm from limbus with weakening procedure to the lateral rectus muscle at the same time

Procedure: Strabismus surgery

Interventions

Strabismus surgeryPROCEDURE

Strengthening of medial rectus muscle or strengthening of medial rectus muscle with weakening of the lateral rectus muscle

Medial rectus advancement with lateral rectus recessionMedial rectus advancement with resection

Eligibility Criteria

Age8 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with consecutive exotropia.
  • Eight years old or more.
  • Cooperative patients.

You may not qualify if:

  • Adduction deficit.
  • Mental disability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Minya, Minya Governorate, 61111, Egypt

Location

MeSH Terms

Conditions

StrabismusExotropia

Condition Hierarchy (Ancestors)

Ocular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Officials

  • Sahar TA Abdelaziz, MD

    Faculty of Medicine, Minia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 9, 2021

First Posted

July 14, 2021

Study Start

August 3, 2020

Primary Completion

October 30, 2021

Study Completion

December 31, 2021

Last Updated

January 26, 2022

Record last verified: 2022-01

Locations

EG(1)