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Clinical evaluation of scleral contact lenses

Non-dispensing clinical evaluation of customised OneFit MED scleral contact lenses

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN16851376
Enrollment
30
Registered
2022-07-07
Start date
2022-07-06
Completion date
Unknown
Last updated
2023-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Presbyopia Eye Diseases Presbyopia

Interventions

Each participant will wear all the study contact lenses in a sequential fashion for about 1 hour and a half each. During each period of wear, contact lens fitting video recordings and photos will be t

Sponsors

CooperVision International Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. 40 or more years of age 2. Have read and understood the Participant Information Sheet in English 3. Have read, signed and dated the Informed Consent 4. Current multifocal contact lens wearer 5. Spectacle refraction: 5.1. Distance: Sphere: -6.00D to + 4.00DS 5.2. Astigmatism: -0.00DC to -1.50DC in each eye 5.3. Near Addition: +0.75D to +2.50D 6. Best corrected visual acuity of at least 20/25 in each eye 7. Have normal eyes with the exception of the need for visual correction 8. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule

Exclusion criteria

Exclusion criteria: 1. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear 2. Use of systemic or ocular medications 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. Any moderate or severe ocular condition observed during the slit lamp examination at the enrolment visit 5. History of herpetic keratitis, ocular surgery or irregular cornea 6. Known pregnancy or lactation during the study period 7. Enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals

Design outcomes

Primary

MeasureTime frame
Contact lens centration in primary and down gaze measured in mm after 40 minutes of wear

Secondary

MeasureTime frame
Corneal clearance measured in mm after 40 minutes of wear

Countries

England, United Kingdom

Contacts

Public ContactDeborah Moore
dmoore@otg.co.uk+44 (0)2072224224

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026