Clinical trial NCT05252871: Assessment of Three Basic Progressive Lens Designs
Official title: Assessment of Three Basic Progressive Lens Designs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: Western University of Health Sciences
Sponsor class: OTHER
Collaborators: name: Hoya Vision Care
First posted: 2022-02-23
Enrollment: 80
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This clinical trial investigates the differences between three different progressive addition lens designs. It is a non-invasive double-masked randomized clinical investigation. For this study, 80 participants will be recruited.

Detailed description: The purpose of the study is to evaluate the preference, adaptability, and visual performance of three progressive lens designs. The difference in these lens designs is a variation of zone sizes for intermediate and near vision. The clinical trial helps manufacturers and eye care practitioners to give detailed suggestions to patients. Study participants will be experienced progressive addition lens wearers, which will be recruited by advertisements, by email, and with direct person-to-person solicitation. The study will be conducted at the Eye Care Institute at the Patient Care Center Western University of Health Sciences, Pomona, CA, 91766. For each participant, the study is completed in around two months and requires three separate visits.

Eligibility criteria: Inclusion Criteria:

* Age: 45 to 70 years old.
* Visual Acuity: far \& near monocular: cc ≥ 20/20 (decimal cc ≥ 1.0)
* Normal binocular vision (at distance \& near: no strabismus on cover testing, aligning prism of less than 2Δ horizontally or vertically, stereoacuity of 2' or better at distance and near).
* Prescription is in the range:

  * Spherical power: less than +/-6.00 D
  * Cylindrical power: less than -2.75 D
  * Addition: 1.50 D - 2.50 D
  * Difference in power (spherical equivalent) between eyes: less than 2.00 D

Exclusion Criteria:

* Have never worn any progressive lens design.
* First prescription for progressive lenses.
* Prescription found during visit#1 varies from current prescription more than 0.50 D in any meridian.
* Currently 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.

Primary outcomes:
measure: Evaluate the Adaptation to Progressive Lens Designs.
timeFrame: Entire study duration (approx. 4 weeks)
Secondary outcomes:
measure: Evaluate the Immediate Preference Among Progressive Lens Designs.
timeFrame: Directly after receiving the lenses (approx. 15 minutes)
measure: Evaluate the Preference of Progressive Lens Designs.
timeFrame: Entire study duration (approx. 4 weeks)
Other outcomes:
Locations:
city: Pomona
country: United States
facility: Western University of Health Sciences
state: California
Study officials:
affiliation: Western University of Health Sciences
name: Frank Spors, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: