Status:
COMPLETED
Assessment of Progressive Lens Designs
Lead Sponsor:
University of Milano Bicocca
Collaborating Sponsors:
Hoya Vision Care
Conditions:
Presbyopia
Eligibility:
All Genders
45-70 years
Phase:
NA
Brief Summary
Non-invasive double-blind randomised comparative study on presbyopic subjects wearing progressive lenses.
Detailed Description
Background and rationale: Nowadays many different types of progressive addition lenses are available for the correction of presbyopia. Progressive addition lenses provide a more natural correction fo...
Eligibility Criteria
Inclusion
- Subjects should be experienced progressive lens designs wearers who have worn their current prescription for at least the last one month.
- PAL wearers with 14 mm corridor
- Age: 45 to 70 years old
- Best Corrected Monocular visual Acuity (decimal) both at distance and near ≥ 1.0;
- Normal binocular vision at distance \& near:
- no strabismus on cover test,
- no fixation disparity (Mallett aligning prism of less than 2Δ horizontally or vertically) at near
- stereoacuity of 60" or better at near;
- New prescription (found at visit #1) is in the range:
- Spherical power: up to +/-6.00;
- Cylindrical power: minus cylinder ≤ 2.5D;
- Addition: 1.50-2.50D;
- Difference in the power (spherical equivalent) between eyes: up to 2.0D
- Understanding and speaking Italian or English to be able to answer questionnaires
- Giving a written consent to participate in the study
Exclusion
- First prescription for progressive lenses.
- Prescription found during visit#1 varies from current prescription more than 0.50D in any meridian
- Wearing Single Vision lenses with accommodative support
- Double vision or prismatic prescription in current glasses;
- Known ocular disease including strabismus, any pathology, any eye surgeries that may affect visual acuity
- Use of systemic or ocular medications that are likely to affect vision
- Balance problem/vertigo problem
- Concurrent participation in other vision-related research
Key Trial Info
Start Date :
October 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 20 2021
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04734522
Start Date
October 19 2020
End Date
September 20 2021
Last Update
September 29 2021
Active Locations (1)
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1
Optics and Optometry of Milano-Bicocca (COMiB), Department of Materials Science - University of Milano-Bicocca
Milan, Italy, 20126