Changes in Refractive Error in Patients With Both Partially Refractive Esotropia and Amblyopia

• Sponsor: Sakarya University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04429659
• Collaborator: (none)
• Enrollment: 58
• Location: 1
• Actual Duration (Months): 8.7
• Patients Per Site Per Month: 6.6

Study Details

Study Description

Brief Summary

To investigate changes in refractive errors and evaluate clinical outcomes of strabismus surgery in patients with both amblyopia and partially refractive esotropia (PAET).Amblyopic patients with PAET were enrolled. Non-amblyopic patients with full refractive accommodative esotropia (RAET) were included in the study as a control group. Preoperative and postoperative best corrected visual acuity (BCVA), spherical equivalent (SE), astigmatism, stereoacuity and deviations at near and distance were evaluated and statistically compared in the patient group. The mean BCVA, SE, astigmatism were compared between the patient and the control groups.

Condition or Disease	Intervention/Treatment	Phase
Refractive Errors; Esotropia; Amblyopia Strabismic

Detailed Description

Purpose: To investigate changes in refractive errors and evaluate clinical outcomes of strabismus surgery in patients with both amblyopia and partially refractive esotropia (PAET).

Material-Method: Amblyopic patients with PAET were enrolled. Non-amblyopic patients with full refractive accommodative esotropia (RAET) were included in the study as a control group. Preoperative and postoperative best corrected visual acuity (BCVA), spherical equivalent (SE), astigmatism, stereoacuity and deviations at near and distance were evaluated and statistically compared in the patient group. The mean BCVA, SE, astigmatism were compared between the patient and the control groups.

Study Design

• Study Type: Observational
• Actual Enrollment: 58 participants
• Observational Model: Case-Control
• Time Perspective: Retrospective
• Official Title: Changes in Refractive Error in Patients With Both Partially Refractive Esotropia and Amblyopia
• Actual Study Start Date: Jan 2, 2019
• Actual Primary Completion Date: Apr 1, 2019
• Actual Study Completion Date: Sep 25, 2019

Arms and Interventions

Arm	Intervention/Treatment
Group 1, patients with amblyopia and partially refractive ET children with both amblyopia and partially refractive accommodative esotropia
Group 2, patients with refractive ET children with refractive esotropia

Outcome Measures

Primary Outcome Measures

1. spherical equivalent [36 months]

   spherical error plus half of the cylindirical error measured by retinoscopy, diopter

2. cylindirical error [36 months]

   cylindirical error measured by retinoscopy, diopter

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 15 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

amblyopic children with partially refractive accommodative esotropia as study group non- amblyopic children with fully refractive accommodative esotropia as control group

-

Exclusion Criteria:

Systemic diseases Neurological disorders and diseases Additional ocular diseases

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sakarya University Ophthalmology Department	Sakarya		Turkey

Sponsors and Collaborators

• Sakarya University

Investigators

• Study Chair: Burcin Cakir, MD, Sakarya University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sakarya University
• ClinicalTrials.gov Identifier: NCT04429659
• Other Study ID Numbers: Sakarya strabismus
• First Posted: Jun 12, 2020
• Last Update Posted: Jun 12, 2020
• Last Verified: Jun 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Amblyopia; Esotropia; Refractive Errors

Study Results

No Results Posted as of Jun 12, 2020