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OCT-guided LALAK in Children

NCT01579643 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2018-04-17

No results posted yet for this study

Summary

The primary goal of the trial is to determine if laser-assisted lamellar anterior keratoplasty (LALAK) will reduce the risks of post-operative complications such as adhesions, glaucoma and cataract that are associated with pediatric penetrating keratoplasty (PK).

Conditions

  • Corneal Opacity

Interventions

PROCEDURE

OCT guided laser-assisted lamellar anterior keratoplasty (LALAK)

1. The top hat-shaped donor cornea graft with tapered brim will be cut using a femtosecond (fs) laser at the eye bank. An anterior diameter of 6.0 mm will be used. The depth of the anterior side cut will match the planned excimer ablation depth. 2. The host cornea bed will be prepared with an excimer laser. 3. Descemet's membrane will be peeled off the graft, and the graft sutured into the host bed.

PROCEDURE

Penetrating Keratoplasty (KP)

1. A trephine is used to perform a full thickness cut of a round area of cornea from the both patient's and donor's cornea. 2. The donor cornea is then sutured where the patient's cornea was.

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • National Eye Institute (NEI)

    collaborator NIH

  • Oregon Health and Science University

    lead OTHER

Principal Investigators

  • Bibiana Reiser, MD · Children's Hospital Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01579643 on ClinicalTrials.gov