Centration of toric contact lenses

Not Applicable

Completed

• Conditions: Astigmatism in myopic children and adolescents; Eye Diseases; Astigmatism

• Registration Number: ISRCTN70442548
• Lead Sponsor: CooperVision International Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-29
• Study Completion: 2022-06-30
• Last Update Posted: 19 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

1. Age 8 to 15 years
2. Current soft contact lens wearers
3. Parent/guardian and participant have read and understood the Participant Information Sheet
4. Parent/guardian and participant have read, signed and dated the Informed Consent and Assent (when applicable)
5. Best corrected visual acuity of at least 20/25 in each eye
6. Have normal eyes with the exception of the need for visual correction
7. Spectacle refraction: -0.75 to -6.00 D Spherical equivalent, cylinder of at least -0.50 D (with at least 80% of participants with a cylinder of at least -0.75 D)
8. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule

Exclusion Criteria

1. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear
2. Newly prescribed (within the past 30 days) use of some systemic medications (such as antihistamines, decongestants, diuretics, muscle relaxants, tranquilizers, stimulants, anti-depressants, anti-psychotics, oral contraceptives) or new prescription eyedrops which is not rewetting/lubricating eyedrops for which contact lens wear could be contraindicated as determined by the investigator
3. Monocular participants (only one eye with functional vision) or participants fit with only one lens
4. Subjects with slit-lamp findings greater than grade 1 (e.g. edema, infiltrates, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival, anterior segment inflammation) as per ISO 11980, any previous history or signs of a contact lens related corneal inflammatory event (past corneal ulcers), or any other ocular abnormality that may contraindicate contact lens wear at the enrolment visit
5. History of herpetic keratitis, ocular surgery or irregular cornea
6. Enrolment of the family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals

Study & Design

• Study Type: Interventional
• Study Design: Not specified