Symmetric vs Asymmetric BLR Recession in Management of Basic IXT With Ocular Dominance

NCT05234957 | Completed Results

• 1 other identifier: RC1-1-2022
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to investigate ocular motor and sensory outcomes of two different strategies of lateral rectus recession; symmetric and asymmetric, in management of basic type intermittent exotropia with ocular dominance.

Conditions

Intermittent Exotropia

Outcome Measures

Primary Outcomes (2)

• Ocular Alignment at Distant Fixation

  ocular alignment in prism diopter (PD) at distant fixation (6 meter) is measured using alternate prism and cover test (APCT) while patient wears refractive correction.

  one year

• Ocular Alignment at Near Fixation

  ocular alignment in prism diopter (PD) at near fixation (1/3 meter) is measured using alternate prism and cover test (APCT) while patient wears refractive correction.

  one year

Secondary Outcomes (2)

• Sensory Status (Stereopsis)

  one year

• Sensory Status (Fusion)

  one year

Study Arms (2)

Group 1

ACTIVE COMPARATOR

Symmetric bilateral lateral rectus recession (S-BLR). The amount of bilateral lateral rectus recession is equally divided between both eyes.

Procedure: Bilateral Lateral Rectus Recession

Group 2

ACTIVE COMPARATOR

Asymmetric bilateral lateral rectus recession (A-BLR). The amount of bilateral lateral rectus recession is asymmetrically divided between both eyes, with 2mm more recession in the non-dominant eye.

Procedure: Bilateral Lateral Rectus Recession

Interventions

Bilateral Lateral Rectus Recession PROCEDURE

Symmetric bilateral lateral rectus muscle recession involves equal recession of both lateral rectus muscles. Asymmetric bilateral lateral rectus muscle recession involves recession of the lateral rectus muscle by 2mm more in the non-dominant eye.

Group 1; Group 2

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Basic-type intermittent exotropia
• Simulated distant-type intermittent exotropia

You may not qualify if:

• Alternating basic-type intermittent exotropia (no ocular dominance)
• Distant-type intermittent exotropia
• Convergence-insufficiency type intermittent exotropia
• Constant exotropia
• Sensory exotropia
• Deep amblyopia
• Paralytic or restrictive exotropia
• Previous extraocular muscle surgery

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University

Banhā, Qalyubiyya, 13511, Egypt

Location

Results Point of Contact

• Title: Dr. Mohamed Farid
• Organization: Benha University

mohamed.farid@fmed.bu.edu.eg

00201003354636

Study Officials

• Mohamed Farid, MD

  Benha University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 10, 2022
• Study Start: April 17, 2022
• Primary Completion: April 18, 2023
• Study Completion: May 18, 2023
• Last Updated: December 10, 2024
• Results First Posted: December 10, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)