Visual Outcomes for Toric Efficacy Study

Not Applicable

Completed

• Conditions: Astigmatism; Myopia
• Interventions: Device: Contact lenses (Soft Multifocal); Device: Contact lenses (Orthokeratology)

• Registration Number: NCT03728218
• Lead Sponsor: University of Houston

Brief Summary

This is a crossover study of two types of contact lenses (toric orthokeratology and soft multifocals). Primary aims are to quantify correction of astigmatism, subjective and objective visual performance, aberrometry, peripheral refraction and bacterial bioburden between toric orthokeratology and soft toric multifocal contact lenses.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-10-12
• Study First Submitted: 2018-10-29
• Study First Submitted QC: 2018-11-01
• Study First Posted: 2018-11-02
• Primary Completion: 2020-03-19
• Study Completion: 2020-03-19
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-10
• Last Update Posted: 2020-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• 18 to 39 years of age (inclusive)
• Able to read and understand the study informed consent
• Plano to -5.00 D (inclusive) vertex corrected sphere power in each eye
• 1.25 to -3.50 D (inclusive) vertex corrected astigmatism in each eye
• Best corrected acuity of 20/25 or better in each eye
• No history of ocular pathology or surgery
• No significant binocular vision or accommodation abnormality (i.e. strabismus, amblyopia)
• No gas permeable lens wear for at least 1 month
• No systemic or ocular contraindications for contact lens wear
• Not pregnant/lactating (by self-report)

Exclusion Criteria

• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Prisoners
• Students for whom one of the principal investigators have direct access to/influence on grades would be consented and seen by another investigator for all visits.
• Pregnant/lactating women (by self-report)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Soft Multifocal Contact lenses	Contact lenses (Soft Multifocal)	-
Orthokeratology Contact lenses	Contact lenses (Orthokeratology)	-

Primary Outcome Measures

Name	Time	Method
Distance low contrast visual acuity	Up to two hours	Monocular and binocular logMAR visual acuity

Secondary Outcome Measures

Name	Time	Method
Residual refractive error measured monocularly by cyclopleged auto-refraction	Up to two hours	Cycloplegic auto-refraction to measure residual myopia/hyperopia and astigmatism

Trial Locations

Locations (1)

University of Houston; 🇺🇸 Houston, Texas, United States