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OpenTrials
Completed

NCT Number: NCT05252871

Assessment of Three Basic Progressive Lens Designs

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.

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Key information

Age range

45 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Western University of Health Sciences

Pomona, California, 91766, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating

Device

Subjects will be wearing three different PAL designs with different geometries of the optical progression.

Primary outcomes

  1. Evaluate the Adaptation to Progressive Lens Designs.

    Time frame: Entire study duration (approx. 4 weeks)

    Evaluate the adaptation to progressive lens designs through a "Satisfaction questionnaire" after 1 week of use of each of the 3 progressive addition lenses.

    Scale titles: Visual Quality Scale: A 5-point scale from a minimum value of 1 to a maximum score of 5. Higher scores mean better outcomes.

Secondary outcomes

  1. Evaluate the Immediate Preference Among Progressive Lens Designs.

    Time frame: Directly after receiving the lenses (approx. 15 minutes)

    Evaluate the immediate preference for progressive lens designs through a "Satisfaction questionnaire" directly after receiving the 3 progressive addition lenses.

    Scale titles: Visual Quality Scale: A 5-point scale from a minimum value of 1 to a maximum score of 5. Higher scores mean better outcomes.

  2. Evaluate the Preference of Progressive Lens Designs.

    Time frame: Entire study duration (approx. 4 weeks)

    Evaluate the final preference of progressive lens designs after wearing each of the 3 PALs for one week.

    Scale title: Preference of Progressive Addition Lenses Scale: "Pair 1", "Pair 2, "Pair 3"

Sponsors and collaborators

Lead sponsor

Western University of Health Sciences

Other

Collaborators

  • Hoya Vision Care

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 23, 2022
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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