Corneal Opacities in Children

Completed

• Conditions: Corneal Opacities

• Registration Number: NCT02117323
• Lead Sponsor: Oregon Health and Science University

Brief Summary

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

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2014-01-14
• Study First Submitted QC: 2014-04-15
• Study First Posted: 2014-04-17
• Primary Completion: 2016-08-31
• Study Completion: 2016-08-31
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-12
• Last Update Posted: 2018-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of suitable subjects	5 years	The primary goal of the study will be to identify subjects suitable for the trial with OCT-guided LALAK. The determination will be based on analysis of clinical history \& OCT corneal images as well as the subjects' willingness to participate in the study.

Trial Locations

Locations (1)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States