Comparison of contact lenses for correction of presbyopia

Not Applicable

• Conditions: Eye Diseases; Presbyopia

• Registration Number: ISRCTN55634631
• Lead Sponsor: Brien Holden Vision Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-04
• Last Update Posted: 17 April 2023
• Study Completion: 2024-06-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

1. 40 or more years of age
2. Current multifocal contact lens wearer
3. Spectacle refraction:
3.1. Distance: Sphere: -5.00D to + 3.00D
3.2. Astigmatism: 0.00 to -0.75D
3.3. Near Spectacle Addition at 40cm
3.4. Medium add presbyopes: +1.50D and +1.75D
3.5. High add presbyopes: +2.00D to +2.50D
4. Best corrected visual acuity of at least 20/25 in each eye
5. Participant has read and understood the Participant Information Sheet
6. Participant has read, signed and dated the Informed Consent
7. Participant willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule

Exclusion Criteria

1. Acute and subacute inflammation or infection of the anterior chamber of the eye
2. Any eye disease, injury or abnormality that affects the cornea, conjunctiva or eyelids that would contraindicate contact lens wear
3. Corneal hypoesthesia (reduced corneal sensitivity), if not aphakic
4. Severe insufficiency of lacrimal secretion (dry eyes)
5. Any systemic disease that may affect the eye or may be exaggerated by wearing contact lenses (e.g. acne and eczema)
6. Allergic reactions of ocular surfaces or adnexa that may be induced or exaggerated by wearing contact lenses or use of contact lens solutions
7. Any active corneal infection (bacterial, fungal, protozoal or viral)
8. 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
9. Monocular participants (only one eye with functional vision) or participants fit with only one lens
10. 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
11. History of corneal refractive surgery
12. Enrolment of the family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals
13. Current wearer of the control contact lenses, MyDay® Multifocal

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall binocular vision satisfaction measured using a 0-100point Visual Analogue Scale (VAS) with anchor descriptors of 0 = Extremely Unsatisfied and 100 = Extremely satisfied, after 1 week of contact lens wear

Secondary Outcome Measures

Name	Time	Method
Mean binocular visual acuity, measured as the mean visual acuity of overall distance and overall near visual acuities, after 1 week of contact lens wear