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Photorefractive Keratectomy for Severe Anisometropia and Isoametropia Associated With Amblyopia

Primary Purpose

Anisometropia, Hyperopia, High Myopia

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Photorefractive keratectomy
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anisometropia

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:.

  • Children aged 2 to 17 with significant anisometropia or isoametropia and amblyopia that have failed traditional treatment for at least 6 months.
  • Anisometropic group:
  • The anisometropia must be at least 3.00 diopters.
  • The amblyopic eye best corrected visual acuity must be at least 2 lines worse than the fellow eye in verbal children
  • Isoametropic group
  • Myopia must be at least -4.00 diopters in both eyes
  • Hyperopia must be at least +4.00 diopters in both eyes
  • Astigmatism must be at least +2.50 diopters in both eyes.

Exclusion Criteria:

  • History of significant corneal abnormality that, in the investigator's opinion, may limit visual rehabilitation.
  • History of known collagen disorder
  • History of known corneal ectasia
  • History of previous herpes simplex keratitis
  • Corneal thickness of less than 450u

Sites / Locations

  • Texas Children's Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Photorefractive keratectomy

Arm Description

The children will undergo PRK in the affected eye(s) using previously derived formulas for PRK.

Outcomes

Primary Outcome Measures

Visual acuity
Snellen equivalent

Secondary Outcome Measures

Refractive error
cycloplegic refraction
Corneal clarity
slit lamp exam

Full Information

First Posted
July 19, 2018
Last Updated
June 28, 2023
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03610997
Brief Title
Photorefractive Keratectomy for Severe Anisometropia and Isoametropia Associated With Amblyopia
Official Title
Photorefractive Keratectomy for Anisometropic and Isoametropic Amblyopia in Children Refractory to Conventional Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2001 (Actual)
Primary Completion Date
August 1, 2028 (Anticipated)
Study Completion Date
October 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Photorefractive keratectomy (PRK) with excimer laser has been used successfully to treat myopia, hyperopia, and astigmatism in adults for over 35 years. Children with high refractive errors that go untreated will develop severe amblyopia. PRK can normalize high refractive errors and potentially improve the visual acuity in affected children. The purpose of this study is to investigate whether children with high anisometropia or isoametropia with amblyopia that are nonresponsive to standard therapy and receive PRK develop better longterm visual acuity.
Detailed Description
Anisometropia is a condition in which one eye has a significantly different refractive error from the other and commonly leads to the development of refractive amblyopia in the affected eye. High isoametropia is the condition in which both eyes have high refractive error and commonly leads to bilateral refractive amblyopia if untreated. Amblyopia is the condition in which vision does not develop fully in the brain due to disuse or misuse of one or both eyes. Typically, in high anisometropia, a contact lens in the eye with the stronger refractive error and/or glasses must be used to correct the refractive error. Commonly, infants and children with this condition refuse to wear the contact lens or glasses because the other eye sees normally. There are other problems in treating high anisometropia with glasses. One is aniseikonia, the condition of image size disparity between the two eyes. This causes difficulty for the brain of the affected person to fuse the images from the two eyes because the image from one eye is much larger than that from the other eye. This results in asthenopia (eye fatigue) and sometimes even diplopia. If the anisometropia is severe, significant amblyopia will result in the eye with the stronger refractive error and, if not treated at an early age, permanent and potentially severe vision loss will result. In high isoametropia, contact lenses or glasses must likewise be used in order for normal vision to develop. Most children with isoametropia will wear glasses well because they cannot see well without them. By contrast, children with developmental delays, chromosomal abnormalities, autism, or attention deficit hyperactivity disorder and high isoametropia very commonly will not wear the needed refractive correction due to strong tactile aversion to anything touching their face or head. If the refractive error is high, significant bilateral (isoametropic) amblyopia will result and, if not treated at an early age, permanent and potentially severe vision loss will result. PRK can normalize high refractive errors and potentially reduce or eliminate the amblyopia in affected children. The purpose of this study is to investigate whether children with high anisometropia or isoametropia with amblyopia that are nonresponsive to standard therapy and receive PRK develop better longterm visual acuity. Secondary outcomes are stability of refractive correction, and corneal health.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anisometropia, Hyperopia, High Myopia, Amblyopia Isometropic, Amblyopia Bilateral, High Astigmatism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Photorefractive Keratectomy
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Photorefractive keratectomy
Arm Type
Other
Arm Description
The children will undergo PRK in the affected eye(s) using previously derived formulas for PRK.
Intervention Type
Procedure
Intervention Name(s)
Photorefractive keratectomy
Primary Outcome Measure Information:
Title
Visual acuity
Description
Snellen equivalent
Time Frame
10 years
Secondary Outcome Measure Information:
Title
Refractive error
Description
cycloplegic refraction
Time Frame
10 years
Title
Corneal clarity
Description
slit lamp exam
Time Frame
10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:. Children aged 2 to 17 with significant anisometropia or isoametropia and amblyopia that have failed traditional treatment for at least 6 months. Anisometropic group: The anisometropia must be at least 3.00 diopters. The amblyopic eye best corrected visual acuity must be at least 2 lines worse than the fellow eye in verbal children Isoametropic group Myopia must be at least -4.00 diopters in both eyes Hyperopia must be at least +4.00 diopters in both eyes Astigmatism must be at least +2.50 diopters in both eyes. Exclusion Criteria: History of significant corneal abnormality that, in the investigator's opinion, may limit visual rehabilitation. History of known collagen disorder History of known corneal ectasia History of previous herpes simplex keratitis Corneal thickness of less than 450u
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evelyn Paysse, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Photorefractive Keratectomy for Severe Anisometropia and Isoametropia Associated With Amblyopia

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