NCT07180199

Brief Summary

Evaluation of the results of surgical correction of V pattern intermittent exotropia without inferior oblique muscle overaction by either performing bilateral lateral rectus recession (BLR) alone or performing bilateral lateral rectus recession asssosiated with upward transposition of lateral rectus muscle insertion

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 2023

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 30, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 11, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
Last Updated

September 18, 2025

Status Verified

September 1, 2025

Enrollment Period

1 year

First QC Date

September 11, 2025

Last Update Submit

September 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Angle of Ocular Deviation

    The degree of ocular misalignment was measured using prism cover test at near and distance fixation. Successful outcome was defined as residual deviation ≤10 prism diopters.

    6 months postoperatively

Secondary Outcomes (1)

  • Postoperative Complications

    6 months postoperatively

Study Arms (2)

Bilateral Lateral Rectus Recession (BLR Recession)

EXPERIMENTAL

Participants underwent bilateral lateral rectus recession procedure alone for correction of large-angle exotropia.

Procedure: Bilateral Lateral Rectus Recession (BLR Recession)

Bilateral Lateral Rectus Recession with Upward Transposition

EXPERIMENTAL

Participants underwent bilateral lateral rectus recession combined with upward transposition of the muscle insertion to enhance alignment in cases of large-angle exotropia.

Procedure: Bilateral Lateral Rectus Recession with Upward Transposition

Interventions

This procedure involved recession of both lateral rectus muscles to reduce large-angle exotropia.

Bilateral Lateral Rectus Recession (BLR Recession)

This procedure involved bilateral lateral rectus recession combined with upward transposition of the insertion to enhance ocular alignment in patients with large-angle exotropia.

Bilateral Lateral Rectus Recession with Upward Transposition

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with V pattern intermittent exotropia (XT increasing by \>10Δ in upgaze compared with Downgaze).
  • No or minimal inferior oblique overaction on both sides (+1)
  • Minimum follow-up period of 6 months after surgical correction of strabismus

You may not qualify if:

  • Structural eye pathology.
  • Significant neurodevelopmental delay.
  • ntermittent exotropia without V pattern.
  • Superior oblique under action.
  • Duane syndrome.
  • Less than 6 months follow up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tanta University

Tanta, El-Gharbia Governorate, Egypt, 31527, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident at Ophthalmology Department, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

First Submitted

September 11, 2025

First Posted

September 18, 2025

Study Start

August 30, 2023

Primary Completion

August 30, 2024

Study Completion

August 30, 2024

Last Updated

September 18, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

Shared Documents
STUDY PROTOCOL
Time Frame
After the end of study for one year.
Access Criteria
The data will be available upon a reasonable request from the corresponding author

Locations