Treating Contact Lens Discomfort With Orthokeratology

NCT ID: NCT03566680

Last Updated: 2020-08-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-07
• Study Completion Date: 2019-06-15

Brief Summary

The primary aim of this study is to understand if orthokeratology can be used to improve contact lens comfort and the secondary aim is understand patient adaptation to orthokeratology.

Detailed Description

Orthokeratology has yet to be fully explored for the treatment of contact lens discomfort (CLD), though some support for this practice exists in the literature. Carracedo et al., Lipson et al., and Garcia-Porta et al. found that orthokeratology resulted in better ocular comfort than soft contact lenses. Nevertheless, all three studies excluded subjects who had been diagnosed with dry eye and all three studies used symptoms surveys that were not specific to assessing CLD. Garcia-Porta et al.'s study was also limited by including both neophytes and established contact lens wearers. Yet, these studies overall suggest that orthokeratology could be used as a treatment for CLD, and one case report has even found that orthokeratology is a viable option for treating contact lens intolerance.

To date, there has yet to be a study fully investigating orthokeratology as an alternative to soft contact lens use in patients with CLD. Therefore, the purpose of this study is to formally investigate if orthokeratology is a good alternative to soft contact lenses for patients who are experiencing CLD or for patients who have dropped out of contact lenses because of CLD. This study will also simultaneously evaluate the neophyte orthokeratology wearing experience with hopes of finding additional means for improving contact lens comfort. Knowing the success of orthokeratology in wearers with CLD will allow practitioners to better help and prescribe for those who may have experienced or at risk for experiencing CLD. It may also be a way to allow patients additional years of contact lens wear.

Conditions

Dry Eye; Contact Lens Complication

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Orthokeratology Group

All subjects will be fit in orthokeratology contact lenses.

Group Type: EXPERIMENTAL

Orthokeratology

Intervention Type: DEVICE

Orthokeratology is a type of contact lens that is worn over night to reduce refractive error, so patients do not need to wear vision correction during the day.

Interventions

Orthokeratology

Orthokeratology is a type of contact lens that is worn over night to reduce refractive error, so patients do not need to wear vision correction during the day.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• A completed comprehensive eye exam within the past two years
• Contact lens discomfort or discontinuation of contact lenses because of discomfort within the past 6 months
• Able to wear the Emerald™ Contact Lens (Oprifocon A, Euclid Systems Corporation)
• Refractive error better than -5.00 diopters with less than 1.50 diopters of cylinder
• Keratometry values between 40.00 D and 46.00 D

Exclusion Criteria

• Past orthokeratology use
• Ocular surgery within the past 12 months
• History of severe ocular trauma
• Active ocular infection or inflammation
• Ocular disease other than dry eye
• Accutane or ocular medication use
• Pregnant or breast feeding
• A condition or situation that may put the subject at significant risk, confound the study results, or may significantly interfere with study participation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Andrew Pucker

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Andrew D Pucker, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

References

Duong K, McGwin G Jr, Franklin QX, Cox J, Pucker AD. Treating Uncomfortable Contact Lens Wear With Orthokeratology. Eye Contact Lens. 2021 Feb 1;47(2):74-80. doi: 10.1097/ICL.0000000000000690.

Reference Type: DERIVED

PMID: 32097182 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

OAN 000520524

Identifier Type: -

Identifier Source: org_study_id