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Goblet Cell Response and Dry Eye Symptoms After PRK and LASIK

NCT00411827 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2024-09-20

No results posted yet for this study

Summary

Purpose: To develop a screening metric by examining both the characteristics of the preoperative tear film and the intracellular signaling pathways of conjunctival goblet cells in order to determine if there are certain characteristics which might predict those patients who will experience serious dry eye symptoms and complications after refractive surgery.

Research Design: This study is a twelve-month prospective non-randomized investigation.

Methodology: In conjunction with psychometric questionnaires and various measures of tear film quality (e.g. Schirmer's test, tear break up time, etc), impression cytology will be used to assess the intracellular signaling pathways of conjunctival goblet cells and to determine if alterations in this pathway exist. Alterations in this pathway would result in a reduced response by the mucin secreting conjunctival goblet cells thereby promoting the development of dry eye after refractive surgery.

Conditions

  • Keratoconjunctivitis Sicca

Interventions

PROCEDURE

PRK with conjunctival impression cytology before and after surgery

PROCEDURE

LASIK with conjunctival impression cytology before and after surgery

LASIK with conjunctival impression cytology before and after surgery

Sponsors & Collaborators

  • Schepens Eye Research Institute

    collaborator OTHER

  • State University of New York College of Optometry

    collaborator OTHER

  • Walter Reed National Military Medical Center

    lead FED

Principal Investigators

  • Richard D Stutzman, MD · WRNMMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2011-02-28
Completion
2016-05-31

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 NCT00411827 on ClinicalTrials.gov