Changes in Refractive Error in Patients With Both Partial... | NCT04429659

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

NCT04429659

Sponsor

Sakarya University

Status

Completed

Last Update Posted

Jun 12, 2020Actual

Enrollment

58Actual

Phase

Not provided

Conditions

Refractive Errors
Esotropia
Amblyopia Strabismic

Interventions

Not provided

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2, 2019Actual

Primary Completion Date

Apr 1, 2019Actual

Completion Date

Sep 25, 2019Actual

First Submitted Date

Jun 9, 2020

First Submission Date that Met QC Criteria

Jun 11, 2020

First Posted Date

Jun 12, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2020

Last Update Posted Date

Jun 12, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

58Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
spherical equivalent	spherical error plus half of the cylindirical error measured by retinoscopy, diopter	36 months
cylindirical error	cylindirical error measured by retinoscopy, diopter	36 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

study population was composed of amblyopic children with partially refractive ET.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Burcin Cakir, MD	Sakarya University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sakarya University Ophthalmology Department		Sakarya			Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D012030	Refractive Errors
D004948	Esotropia
D000550	Amblyopia

Ancestor Terms

ID	Term
D005128	Eye Diseases
D013285	Strabismus
D015835	Ocular Motility Disorders
D003389	Cranial Nerve Diseases

Browse Leaves

Not provided

Browse Branches

Not provided