NCT04199286

Brief Summary

This study was done in alternating strabismus patients to compare symmetrical muscle surgery and asymmetrical one as regard efficacy and lateral incomitance after surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

December 11, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

December 21, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2021

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

1.2 years

First QC Date

December 11, 2019

Last Update Submit

June 15, 2021

Conditions

Strabismus

Outcome Measures

Primary Outcomes (1)

  • There was 95% success rate in asymmetrical group compared with 90% in symmetrical one

    This result was measured by simultaneous prism cover test and expressed in prism diopter

    one and half year

Study Arms (2)

Asymmetrical surgery

ACTIVE COMPARATOR

This asymmetrical horizontal muscle surgery done as recess-resect in one eye or 3 muscle surgery

Procedure: symmetrical and asymmetrical horizontal strabismus surgery

Symmetrical

ACTIVE COMPARATOR

This symmetrical horizontal muscle surgery includes bilateral medial rectus recession in esotropia cases or bilateral lateral rectus recession in exotropia

Procedure: symmetrical and asymmetrical horizontal strabismus surgery

Interventions

symmetrical and asymmetrical horizontal strabismus surgeryPROCEDURE

surgery was done on the medial rectus muscle on both eyes, lateral rectus muscle in both eyes or medial and lateral rectus muscle in one eye

Asymmetrical surgerySymmetrical

Eligibility Criteria

Age4 Years - 28 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • more than 3 years old.
  • alternating esotropia or exotropia

You may not qualify if:

  • unilateral strabismus
  • paralytic or restrictive strabismus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Medicine

Minya, Minya Governorate, 61111, Egypt

Location

Mohamed F K Ibrahiem

Minya, 61111, Egypt

Location

Related Publications (1)

  • Ismail AA, Abdelkader MF, Mohamed AA, Abdelaziz ST. Evaluation of Efficacy and Lateral Gaze Incomitance in Symmetrical and Asymmetrical Surgery for Concomitant Esotropia and Exotropia. Clin Ophthalmol. 2021 Aug 26;15:3613-3621. doi: 10.2147/OPTH.S326659. eCollection 2021.

    PMID: 34471346DERIVED

MeSH Terms

Conditions

Strabismus

Condition Hierarchy (Ancestors)

Ocular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Officials

  • Sahar TA Abdelaziz, MD

    Assistant professor

    PRINCIPAL INVESTIGATOR

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
Assistant Professor

Study Record Dates

First Submitted

December 11, 2019

First Posted

December 13, 2019

Study Start

December 21, 2019

Primary Completion

March 1, 2021

Study Completion

June 14, 2021

Last Updated

June 18, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

EG(2)