Multifocal Contact Lenses Fitting Methods Comparison

CooperVision

Status: Completed

Conditions: Presbyopia

Treatments: Device: Test Lenses (test fitting approach); Device: Control Lenses (control fitting approach)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05734846

CV-22-49

Details and patient eligibility

About

The purpose of this study was to compare the clinical performance of two fitting approaches for multifocal contact lenses.

Full description

This was a prospective, cross-over, double-masked (participants and investigator), randomized order of testing study. It compared two fitting approaches for silicone hydrogel multifocal contact lenses to assess which method achieved greater vision satisfaction and performance.

Enrollment: 25 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• At least 40 years old;
• Have read and understood the Participant Information Sheet;
• Have read, signed and dated the Informed Consent;
• Best corrected visual acuity of at least 20/25 in each eye;
• Have normal eyes with the exception of the need for visual correction;
• Current multifocal contact lens wearer;
• Spectacle refraction:

Distance: Sphere: -6.00D to + 4.00D Astigmatism: 0.00D to -0.75D Near Addition: Established Presbyopes: +1.50D & +1.75D

• Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule.

Exclusion criteria

• Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
• Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator;
• Monocular participants (only one eye with functional vision) or participants fit with only one lens;
• Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit;
• History of herpetic keratitis, ocular surgery or irregular cornea;
• Known pregnancy or lactation during the study period;
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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25 participants in 2 patient groups

Control Lenses, then Test Lenses

Experimental group

Description:

Participants wore the Control Lenses for 1 week, then crossed over to the Test Lenses for 1 week.

Treatment:

Device: Test Lenses (test fitting approach)

Device: Control Lenses (control fitting approach)

Test Lenses, then Control Lens

Experimental group

Description:

Participants wore the Test Lenses for 1 week, then crossed over to the Control Lenses for 1 week.

Treatment:

Device: Test Lenses (test fitting approach)

Device: Control Lenses (control fitting approach)