PresbyopiaTBPDNCT04734522
Assessment of 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 University of Milano Bicocca at 1 site in Italy.
Trial summary
Non-invasive double-blind randomised comparative study on presbyopic subjects wearing progressive lenses. Read more about this study
- Who is it for?
- Ages 45 to 70 years
- 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 siteItaly
- Study dates
- 19 Oct 2020to 20 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Show all 15Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Optics and Optometry of Milano-Bicocca (COMiB), Department of Materials Science - University of Milano-Bicocca
Milan, 20126
About this study
Non-invasive double-blind randomised comparative study on presbyopic subjects wearing progressive lenses.
Read the 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 for presbyopic people due to a gradual and progressive increase of lens power from far area through the intermediate portion to the near area. However, some patients still experience adaptation problems.
The primary purpose of the study is to evaluate the preference, adaptability and visual performance of progressive lens designs (up to three designs).
Study procedures:
Each participant is required to wear all pairs of spectacles one after another, each pair for one week.
Each participant will be required to visit the optometry clinic (at University of Milano Bicocca) three times:
Visit #1: Screening based on inclusion criteria, Informed Consent Form (ICF) form signing, Optometric exam and choice of the frame.
Subjects who will pass the inclusion/exclusion screening will be asked to sign the ICF and enrolled for the optometric exam. Subjects will choose the spectacle frame and all individual fitting parameters will be measured for lens' manufacturing.
Visit #2: Subjects will receive three marked pairs of progressive lenses. The three spectacle frames will be adjusted to fit properly on the subject' face. After 10-15 min of wearing of the first pair of lenses, each subject will be asked to answer to a questionnaire.
Visit #3 (last visit): questionnaires should be returned; the last comparison question will be answered during this visit, and subject will choose the best pair.
At the end of the study each participant will be entitled to get one pair of progressive lenses available in the market.
Subject population:
Presbyopic subjects have been already wearing any progressive additional lens (PAL) designs.
Number of Subjects:
40 +/- 2 subjects, the specified PAL design wearers and 40 +/- 2 the other PAL design wearers to be enrolled and signed the informed consent form.
Each subject will be wearing three different PAL designs. Subjects will be asked to choose one pair of spectacles (design) which they like the most.
Randomisation:
This study adopts a stratified permuted block randomisation to reduce an evaluation bias by the wearing sequence and prescriptions. The mean of both eyes' prescriptions is set as a single stratification factor.
Frames:
Each subject will choose a model of spectacle frame. Three identical frames will be taken for each subject.
Lenses:
- Lenses will be produced in EU
- Three different lens designs will be tested in the study.
- Conditions
- Presbyopia
- Being tested
- Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating
- Keywords
- presbyopia, progressive addition lenses
- 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 |
|---|---|---|
| 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 preference among progressive lens designs
Evaluate the preference among progressive lens designs through a "First impression questionnaire" after 10-15 minutes of wearing each of the 3 PALs, a "Final satisfaction questionnaire" after 1 week of use of each of the 3 PALs and a "Comparison questionnaire" at the end of the three trial periods of all the three types of PALs.
Measured: Entire study duration (approx. 4 weeks)
Secondary outcomes (2)
Evaluate the adaptability of progressive lens designs.
Evaluate adaptability of progressive lens designs through a "Final satisfation questionnaire" after one week of use of each of the three PALs.
Measured: Entire study duration (approx. 4 weeks)
Evaluate visual performance of progressive lens designs.
Evaluate the visual performance of progressive lens designs measured both after 10-15 minutes of wear and after one week by psychophysical analysis (visual acuity at high contrast at near and at distance, rate/accuracy of reading test at high contrast and at near).
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 posted2 Feb 2021
- Study start19 Oct 2020
- Primary completion31 Aug 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Collaborators
- Hoya Vision Care
- Responsible party
- Principal investigator, Silvia Tavazzi, University of Milano Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04734522
- Sponsor's protocol ID
- 2019-01
- Acronym
- TBPD
- Status last verified
- Sep 2021
- First submitted
- 15 Jan 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Progressive Lens Designs
- ClinicalTrials.gov ID
- NCT04734522
- Acronym / sponsor ID
- TBPD / 2019-01
- Conditions
- Presbyopia
- Keywords
- presbyopia, progressive addition lenses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Collaborators
- Hoya Vision Care
- Study start
- 19 Oct 2020 (actual)
- Primary completion
- 31 Aug 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 2 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 for presbyopic people due to a gradual and progressive increase of lens power from far area through the intermediate portion to the near area. However, some patients still experience adaptation problems.
The primary purpose of the study is to evaluate the preference, adaptability and visual performance of progressive lens designs (up to three designs).
Study procedures:
Each participant is required to wear all pairs of spectacles one after another, each pair for one week.
Each participant will be required to visit the optometry clinic (at University of Milano Bicocca) three times:
Visit #1: Screening based on inclusion criteria, Informed Consent Form (ICF) form signing, Optometric exam and choice of the frame.
Subjects who will pass the inclusion/exclusion screening will be asked to sign the ICF and enrolled for the optometric exam. Subjects will choose the spectacle frame and all individual fitting parameters will be measured for lens' manufacturing.
Visit #2: Subjects will receive three marked pairs of progressive lenses. The three spectacle frames will be adjusted to fit properly on the subject' face. After 10-15 min of wearing of the first pair of lenses, each subject will be asked to answer to a questionnaire.
Visit #3 (last visit): questionnaires should be returned; the last comparison question will be answered during this visit, and subject will choose the best pair.
At the end of the study each participant will be entitled to get one pair of progressive lenses available in the market.
Subject population:
Presbyopic subjects have been already wearing any progressive additional lens (PAL) designs.
Number of Subjects:
40 +/- 2 subjects, the specified PAL design wearers and 40 +/- 2 the other PAL design wearers to be enrolled and signed the informed consent form.
Each subject will be wearing three different PAL designs. Subjects will be asked to choose one pair of spectacles (design) which they like the most.
Randomisation:
This study adopts a stratified permuted block randomisation to reduce an evaluation bias by the wearing sequence and prescriptions. The mean of both eyes' prescriptions is set as a single stratification factor.
Frames:
Each subject will choose a model of spectacle frame. Three identical frames will be taken for each subject.
Lenses:
- Lenses will be produced in EU
- Three different lens designs will be tested in the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (8 listed)
- 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
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 | The other PAL design wearers, The specified PAL design wearers |
Primary outcome
Evaluate the preference among progressive lens designs
Time frame: Entire study duration (approx. 4 weeks)
Evaluate the preference among progressive lens designs through a "First impression questionnaire" after 10-15 minutes of wearing each of the 3 PALs, a "Final satisfaction questionnaire" after 1 week of use of each of the 3 PALs and a "Comparison questionnaire" at the end of the three trial periods of all the three types of PALs.
2 secondary outcomes
Evaluate the adaptability of progressive lens designs.
Time frame: Entire study duration (approx. 4 weeks)
Evaluate visual performance of progressive lens designs.
Time frame: Entire study duration (approx. 4 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 University of Milano Bicocca at 1 site in Italy.
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 15 inclusion and 8 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 29 Sep 2021. 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 Italy. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 preference among 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 29 Sep 2021.