PresbyopiaNCT05252871
Assessment of Three Basic Progressive Lens Designs
A study testing Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating in people with Presbyopia, run by Western University of Health Sciences at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 45 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Presbyopia
- What is being tested?
- Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2021to 6 Jun 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- Use of systemic or ocular medications that are likely to affect vision.
- Balance problem/vertigo problem.
- Concurrent participation in other vision-related research.
Trial locations and contacts
1 site in 1 country.
United States1 site
Western University of Health Sciences
Pomona, California, 91766
About this study
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.
- Conditions
- Presbyopia
- Being tested
- Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coatingDevice
Subjects will be wearing three different PAL designs with different geometries of the optical progression.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: The specified PAL design wearers | Experimental | Subjects who have been already wearing any from specified design type of PAL Receives: Device: Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating |
| The other PAL design wearers | Active comparator | Subjects who have been already wearing any from the other design type of PAL Receives: Device: Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Entire study duration (approx. 4 weeks)
Secondary outcomes (2)
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.
Measured: Directly after receiving the lenses (approx. 15 minutes)
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"
Measured: Entire study duration (approx. 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2022
- Study start9 Dec 2021
- Primary completion6 Jun 2022
- Study completion6 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Hoya Vision Care
- Responsible party
- Sponsor
- Investigators
- Frank Spors, Ph.D., Principal investigator, Western University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05252871
- Sponsor's protocol ID
- P21/IRB/065
- Status last verified
- Jul 2024
- First submitted
- 3 Jan 2022
- Last updated
- 15 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Three Basic Progressive Lens Designs
- ClinicalTrials.gov ID
- NCT05252871
- Acronym / sponsor ID
- P21/IRB/065
- Conditions
- Presbyopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Western University of Health SciencesUniversity, hospital or other
- Collaborators
- Hoya Vision Care
- Study start
- 9 Dec 2021 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 23 Feb 2022 (actual)
- Results
- Posted 15 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: The specified PAL design wearers | Experimental | Device: Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coatingSubjects who have been already wearing any from specified design type of PAL |
| The other PAL design wearers | Active comparator | Device: Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coatingSubjects who have been already wearing any from the other design type of PAL |
Who may qualify
- Ages
- 45 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coatingSubjects will be wearing three different PAL designs with different geometries of the optical progression. | Device | Experimental: The specified PAL design wearers, The other PAL design wearers |
Primary outcome
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.
2 secondary outcomes
Evaluate the Immediate Preference Among Progressive Lens Designs.
Time frame: Directly after receiving the lenses (approx. 15 minutes)
Evaluate the Preference of Progressive Lens Designs.
Time frame: Entire study duration (approx. 4 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank Spors, Ph.D. principal investigator
Western University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating in people with Presbyopia, run by Western University of Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the Adaptation to Progressive Lens Designs. (time frame: Entire study duration (approx. 4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2024.