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CompletedNCT05252871Updated Aug 15, 2024Results posted

Assessment of Three Basic Progressive Lens Designs

An interventional study of Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating in Presbyopia, sponsored by Western University of Health Sciences. Completed at 1 site in United States. Open to participants aged 45 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-15.

Sponsored by Western University of Health Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
45 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Presbyopia

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03

In context

Presbyopia

336 studies on the registry are indexed under Presbyopia; 35 are open to participants now.

This study's enrollment of 80 is above the median of 61 across 276 interventional studies indexed under Presbyopia.

Browse Presbyopia studies →

Lead sponsor

Western University of Health Sciences is the lead sponsor of 22 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    Experimental: The specified PAL design wearers

    Subjects who have been already wearing any from specified design type of PAL

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

  • Active comparator
    The other PAL design wearers

    Subjects who have been already wearing any from the other design type of PAL

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

Interventions

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

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

06

What researchers measure

Primary outcomes

  1. Evaluate the Adaptation to Progressive Lens Designs.

    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.

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

Secondary outcomes

  1. Evaluate the Immediate Preference Among Progressive Lens Designs.

    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.

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

  2. Evaluate the Preference of Progressive Lens Designs.

    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"

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

07

Results

Posted Aug 15, 2024
Limitations and caveats
There are no limitations to be reported. The study went as planned.

Participant flow

Participant flow — Overall Study
MilestoneExperimental: The Specified PAL Design WearersThe Other PAL Design Wearers
Started4040
Completed4040
Not completed00

Outcome measures

PrimaryEvaluate the Adaptation to Progressive Lens Designs.

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.

Time frame:
Entire study duration (approx. 4 weeks)
Reported as:
Mean · score on a scale
Evaluate the Adaptation to Progressive Lens Designs.
score on a scaleExperimental: The Specified PAL Design Wearers, Wearing Pair 1The Other PAL Design Wearers, Wearing Pair 1Experimental: The Specified PAL Design Wearers, Wearing Pair 2The Other PAL Design Wearers, Wearing Pair 2Experimental: The Specified PAL Design Wearers, Wearing Pair 3The Other PAL Design Wearers, Wearing Pair 3
Evaluate the Adaptation to Progressive Lens Designs.4.125 ± 0.8224.025 ± 1.053.875 ± 0.9923.725 ± 0.9874.300 ± 0.9394.150 ± 0.864
SecondaryEvaluate the Immediate Preference Among Progressive Lens Designs.

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.

Time frame:
Directly after receiving the lenses (approx. 15 minutes)
Reported as:
Mean · score on a scale
Evaluate the Immediate Preference Among Progressive Lens Designs.
score on a scaleExperimental: The Specified PAL Design Wearers, Wearing Pair 1The Other PAL Design Wearers, Wearing Pair 1Experimental: The Specified PAL Design Wearers, Wearing Pair 2The Other PAL Design Wearers, Wearing Pair 2Experimental: The Specified PAL Design Wearers, Wearing Pair 3The Other PAL Design Wearers, Wearing Pair 3
Evaluate the Immediate Preference Among Progressive Lens Designs.4.550 ± 0.7144.400 ± 0.7094.625 ± 0.6674.450 ± 0.7834.625 ± 0.5684.400 ± 0.672
SecondaryEvaluate the Preference of Progressive Lens Designs.

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"

Time frame:
Entire study duration (approx. 4 weeks)
Reported as:
Number · participants
Evaluate the Preference of Progressive Lens Designs.
participantsExperimental: The Specified PAL Design Wearers, Wearing Pair 1The Other PAL Design Wearers, Wearing Pair 1Experimental: The Specified PAL Design Wearers, Wearing Pair 2The Other PAL Design Wearers, Wearing Pair 2Experimental: The Specified PAL Design Wearers, Wearing Pair 3The Other PAL Design Wearers, Wearing Pair 3
Evaluate the Preference of Progressive Lens Designs.11161091915

Adverse events

Collected over Through study completion, 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Experimental: The Specified PAL Design Wearers, Wearing Pair 10/40 (0%)0/40 (0%)0/40 (0%)
The Other PAL Design Wearers, Wearing Pair 10/40 (0%)0/40 (0%)0/40 (0%)
Experimental: The Specified PAL Design Wearers, Wearing Pair 20/40 (0%)0/40 (0%)0/40 (0%)
The Other PAL Design Wearers, Wearing Pair 20/40 (0%)0/40 (0%)0/40 (0%)
Experimental: The Specified PAL Design Wearers, Wearing Pair 30/40 (0%)0/40 (0%)0/40 (0%)
The Other PAL Design Wearers, Wearing Pair 30/40 (0%)0/40 (0%)0/40 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Experimental: The Specified PAL Design WearersThe Other PAL Design WearersTotal
<=18 years000
Between 18 and 65 years353772
>=65 years538
Age, Continuous
Age, Continuous(years)Experimental: The Specified PAL Design WearersThe Other PAL Design WearersTotal
Mean55.3 ± 7.1155.6 ± 6.4255.5 ± 6.73
Sex: Female, Male
Sex: Female, Male(Participants)Experimental: The Specified PAL Design WearersThe Other PAL Design WearersTotal
Female252146
Male151934
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Experimental: The Specified PAL Design WearersThe Other PAL Design WearersTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(Participants)Experimental: The Specified PAL Design WearersThe Other PAL Design WearersTotal
United States404080
08

Study locations

1 site
  • Western University of Health Sciences
    Pomona, California 91766, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Dec 2021 to primary completion in Jun 2022, 5 months.

Results were first posted in Aug 2024, 2 years 2 months after primary completion.

Of 42 non-industry interventional studies with no phase under Presbyopia, half reached primary completion within 15 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 23. This study's 5 months is below that.

Counting every sponsor, half of 129 studies reached it within 10 months; a quarter within 3 and three quarters within 23.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 3, 2022
First posted
Feb 23, 2022
StartActual
Dec 9, 2021
Primary completionActual
Jun 6, 2022
CompletionActual
Jun 6, 2022
Results first posted
Aug 15, 2024
Last update
Aug 15, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 15, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05252871
Lead sponsor
Western University of Health Sciences
Collaborators
Hoya Vision Care
Responsible party
Sponsor
First posted
Feb 23, 2022
Start date
Dec 9, 2021
Primary completion
Jun 6, 2022
Completion
Jun 6, 2022
Results posted
Aug 15, 2024
Last update
Aug 15, 2024

Study contacts

Frank Spors, Ph.D.
principal investigator · Western University of Health Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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