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Changes in the Tear Film With Scleral Contact Lens Wear for Keratoconic Eyes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02806921
Recruitment Status : Completed
First Posted : June 21, 2016
Last Update Posted : June 27, 2019
Sponsor:
Collaborator:
Bausch & Lomb Incorporated
Information provided by (Responsible Party):
Luigina Sorbara, University of Waterloo

Brief Summary:
The purpose of this study is to investigate changes in the level of inflammatory mediators in the tear film of scleral contact lens wearers in a keratoconic population.

Condition or disease Intervention/treatment Phase
Keratoconus Device: ZenLens Not Applicable

Detailed Description:
Scleral contact lenses are rigid gas permeable lenses designed to rest on the sclera while vaulting over the cornea with a fluid reservoir. The use of scleral contact lenses has become the current standard of practice as a nonsurgical management of corneal ectasia and ocular surface diseases. Cases have been recently presented of scleral lens wearers exhibiting adverse corneal findings and conjunctival injection from lens wear. These findings are likely associated with the mechanical and hypoxic effects due to poor fitting characteristics at the limbal area. Tear film analysis detecting changes in the levels of proteinases and cytokines have helped researchers gain a better understanding of the pathophysiology of complications in soft contact lenses wearers, dry eye, and keratoconus. Ultimately, this study will provide insights in relating scleral lens fitting characteristics and corneal and limbal physiological responses.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Protease and Cytokine Composition in Post Lens Tear Reservoir of Scleral Lenses for Keratoconic Eyes
Actual Study Start Date : August 2016
Actual Primary Completion Date : January 30, 2018
Actual Study Completion Date : February 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear Tears

Arm Intervention/treatment
Active Comparator: ZenLens with Low limbal clearance
Scleral contact lens designed to provide approximately 25 microns of limbal clearance.
Device: ZenLens
The ZenLens™ semi-scleral lenses are manufactured by Alden Optic Laboratories Inc., Lancaster, NY. They will be made in Boston XO material.

Active Comparator: ZenLens with High limbal clearance
Scleral contact lens designed to provide approximately 80 microns of limbal clearance.
Device: ZenLens
The ZenLens™ semi-scleral lenses are manufactured by Alden Optic Laboratories Inc., Lancaster, NY. They will be made in Boston XO material.




Primary Outcome Measures :
  1. Tear Protein [ Time Frame: 2 weeks of lens wear with daily schedule of 6-8 hours. ]
    To measure the level proteases and cytokines in each of the samples using Meso Scale Discovery system (MSD-ECL).


Secondary Outcome Measures :
  1. Comfort [ Time Frame: 2 weeks of lens wear with daily schedule of 6-8 hours. ]
    Participants will be asked to rate their ocular comfort, dryness, burning and vision with the contact lenses.

  2. Bulbar and limbal hyperemia [ Time Frame: 2 weeks of lens wear with daily schedule of 6-8 hours. ]
    The eyes of the participants will be imaged using the Keratograph® 5.

  3. Corneal thickness [ Time Frame: 2 weeks of lens wear with daily schedule of 6-8 hours. ]
    Their corneal thickness will be measured with the Visante OCT.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Had been diagnosed with keratoconus in at least one eye.
  • Is at least 18 years of age and has full legal capacity to volunteer.
  • Has read and understood the information consent letter.
  • Is willing and able to follow instructions and maintain the appointment schedule.

Exclusion Criteria:

  • Is using any topical medications that will affect ocular health.
  • Has any ocular pathology or severe insufficiency of lacrimal secretion (severe dry eyes) that would affect the wearing of contact lenses.
  • Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
  • Has any clinically significant lid or conjunctival abnormalities and active neovascularization.
  • Is aphakic.
  • Has undergone any corneal surgery.
  • Is participating in any other type of eye related clinical or research study.
  • Has any known allergies or sensitivity to the diagnostic pharmaceuticals or products, such as fluorescein, used in this study.
  Study Documents (Full-Text)

Documents provided by Luigina Sorbara, University of Waterloo:
Informed Consent Form  [PDF] June 17, 2016

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Responsible Party: Luigina Sorbara, Associate Professor, University of Waterloo
ClinicalTrials.gov Identifier: NCT02806921    
Other Study ID Numbers: 14620
First Posted: June 21, 2016    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Luigina Sorbara, University of Waterloo:
Scleral Contact Lens
Tear Proteases
Tear Cytokines
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases