Corneal Opacities in Children

NCT ID: NCT02117323

Last Updated: 2018-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2016-08-31

Brief Summary

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A prospective observational study on corneal opacities in infants and children (1 month to 18 years old) will be conducted at CHLA. Most of these cases will be due to congenital corneal opacity (e.g. Peter's anomaly, mucopolysacharidoses) or scarring due to infectious keratitis. Sixty (60) subjects will be recruited. The children will be examined under anesthesia with a portable slit-lamp and OCT. An iVue OCT system (Optovue) attached to an operating microscope-style mount at CHLA will be used for the intraoperative scans. Both cross-sectional and 3-D OCT scans will be performed to assess opacity depth, pachymetry map, endothelial defects, and any abnormal adhesion between the cornea, iris and lens. The anterior chamber angle will also be imaged with cross-sectional OCT to assess angle depth, trabecular meshwork, Schwalbe's line, and possible peripheral iridocorneal adhesion or posterior embryotoxon. OCT of the crystalline lens will be obtained to assess the presence of cataract. Slit-lamp photography will be obtained, and gonioscopy will be performed if indicated. Corneal diameter will be measured with a caliper, and intraocular pressure will be measured with a tonopen (Reichert).

Detailed Description

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Conditions

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Corneal Opacities

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Infants and children (1 month to 18 years of age) with corneal opacity requiring a thorough eye examination.

Exclusion Criteria

* Inability to give informed consent.
* Inability to maintain stable fixation for OCT imaging.
* Inability to commit to required visits to complete the study.
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Eye Institute (NEI)

NIH

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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David Huang

David Huang, MD, PhD, Weeks Professor of Ophthalmology, Oregon Health and Science University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bibiana Reiser, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Los Angeles

Locations

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Children's Hospital Los Angeles

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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R01EY018184

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CCI-10-00084

Identifier Type: -

Identifier Source: org_study_id

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