AmetropiaNCT04617080
Safety and Efficacy of Different Add Powers With a New Presbyopic Lasik Treatment Algorithm
A study testing SUPRACOR Regular and SUPRACOR Strong in people with Ametropia, run by Bausch & Lomb Incorporated at 1 site in Philippines.
Trial summary
This is a prospective, comparative, randomized, controlled, open-label, single-surgeon, single-center PMCF clinical study whereby presbyopic patients undergoing refractive surgery will receive a SUPRACOR treatment for the correction in the non-dominant eye and a PROSCAN refractive treatment in the dominant eye to… Read more about this study
- Who is it for?
- Ages 40 to 65 years
- Conditions the study is for
- Ametropia
- What is being tested?
- SUPRACOR Regular and SUPRACOR Strong
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePhilippines
- Study dates
- 26 Jan 2020to 28 Feb 2024
- 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 40 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- presbyopia
- willingness for a refractive presbyopia correction
- signed informed consent form
Who cannot join
- ocular comorbidity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Clinical Study to Evaluate the Safety and Efficacy of Different Add Powers With a New Presbyopic Lasik Treatment Algorithm
This is a prospective, comparative, randomized, controlled, open-label, single-surgeon, single-center PMCF clinical study whereby presbyopic patients undergoing refractive surgery will receive a SUPRACOR treatment for the correction in the non-dominant eye and a PROSCAN refractive treatment in the dominant eye to correct for ametropia.
The participants will be randomized to either a SUPRACOR regular (100%) or SUPRACOR strong (130%) treatment with a 1:1 ratio.
- Conditions
- Ametropia
- Being tested
- SUPRACOR Regular, SUPRACOR Strong
- Medical subject headings
- Refractive Errors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SUPRACOR RegularProcedure or surgery
SUPRACOR algorithm with regular (100%) ablation profile. SUPRACOR is a presbyopic algorithm that consists of a pre-calculated pulse pattern combined to the refractive pattern to combine near, intermediate and distance vision correction.
SUPRACOR StrongProcedure or surgery
SUPRACOR algorithm with strong (130%) ablation profile. SUPRACOR is a presbyopic algorithm that consists of a pre-calculated pulse pattern combined to the refractive pattern to combine near, intermediate and distance vision correction.
| Study group | Role | What they receive |
|---|---|---|
| SUPRACOR Regular | Active comparator | Not described Receives: Procedure: SUPRACOR Regular |
| SUPRACOR Strong | Experimental | Not described Receives: Procedure: SUPRACOR Strong |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular Uncorrected Distance Visual Acuity (UDVA)
The visual acuity measurements will be assessed using Clinical Trial Suite (M\&S Technologies, Niles, IL, USA) at 4 m in LogMAR scale under photopic light conditions.
Measured: 3 months follow up
Secondary outcomes (13)
Monocular Uncorrected Distance Visual Acuity (UDVA)
The visual acuity measurements will be assessed using Clinical Trial Suite (M\&S Technologies, Niles, IL, USA) at 4 m in LogMAR scale under photopic light conditions.
Measured: 3 months follow up
Monocular Corrected Distance Visual Acuity (CDVA)
The visual acuity measurements will be assessed using Clinical Trial Suite (M\&S Technologies, Niles, IL, USA) at 4 m in LogMAR scale under photopic light conditions. Corrected means spectacle corrected.
Measured: 3 months follow up
Binocular Corrected Distance Visual Acuity (CDVA)
The visual acuity measurements will be assessed using Clinical Trial Suite (M\&S Technologies, Niles, IL, USA) at 4 m in LogMAR scale under photopic light conditions. Corrected means spectacle corrected.
Measured: 3 months follow up
Monocular Uncorrected Intermediate Visual Acuity (UIVA)
The visual acuity measurements will be assessed using Clinical Trial Suite (M\&S Technologies, Niles, IL, USA) at 80 cm (intermediate distance) in LogMAR scale under photopic light conditions.
Measured: 3 months follow up
Binocular Uncorrected Intermediate Visual Acuity (UIVA)
The visual acuity measurements will be assessed using Clinical Trial Suite (M\&S Technologies, Niles, IL, USA) at 80 cm (intermediate distance) in LogMAR scale under photopic light conditions.
Measured: 3 months follow up
Monocular Uncorrected Near Visual Acuity (UNVA)
The visual acuity measurements will be assessed using Clinical Trial Suite (M\&S Technologies, Niles, IL, USA) at 40 cm (near distance) in LogMAR scale under photopic light conditions.
Measured: 3 months follow up
Binocular Uncorrected Near Visual Acuity (UNVA)
The visual acuity measurements will be assessed using Clinical Trial Suite (M\&S Technologies, Niles, IL, USA) at 40 cm (near distance) in LogMAR scale under photopic light conditions.
Measured: 3 months follow up
Binocular Defocus Curve
To assess the visual acuity for different distances, defocus curves under photopic light conditions will be measured using Clinical Trial Suite (M\&S Technologies, Niles, IL, USA) device at 4m. This test is performed with best distance corrected refraction and spherical additions ranging from -4.5 D to +1.0 D in 0.5D steps.
Measured: 3 months follow up
Binocular Contrast sensitivity
The contrast sensitivity test consists in assessing the possibility to distinguish the alternation of white and grey fringes of difference contrast with difference frequency. Contrast sensitivity will be assessed under photopic and mesopic light conditions using Clinical Trial Suite (M\&S Technologies, Niles, IL, USA) device at 2.5 m.
Measured: 3 months follow up
Halo Photic phenomena
The amount and disturbance of photic halo side effects will be assessed by two methods: 1) Halo and Glare simulator: With this software tool the particant mimics the individual vision perception by adjusting a typical night scene image with the intensity and size of glare and halo; 2) Siepser Glarometer (Gulden Ophthalmics, Elkins Park, PA 19027). This is a target-like device that measures and quantifies post-operative glare. The measurement is of the participants' actual scope and range of monocular glare and halo.
Measured: 3 months follow up
Glare Photic phenomena
The amount and disturbance of photic glare side effects will be assessed by two methods: 1) Halo and Glare simulator: With this software tool the particant mimics the individual vision perception by adjusting a typical night scene image with the intensity and size of glare and halo; 2) Siepser Glarometer (Gulden Ophthalmics, Elkins Park, PA 19027). This is a target-like device that measures and quantifies post-operative glare. The measurement is of the participants' actual scope and range of monocular glare and halo.
Measured: 3 months follow up
Patient-Reported Spectacle Independence Questionnaire (PRSIQ)
The Patient-Reported Spectacle Independence Questionnaire (PRSIQ) is comprised of 3 questions about the need for glasses or contacts in the past 7 days for distance vision (at least 1.5 meters (m) away), intermediate vision (0.5 m to 1.5 m away), and near vision (< 0.5 m away). Possible scores range from 1 to 5, with 1 = All of the time and 5 = None of the time for six of the questions; 3 of these questions ask the question in a positive way and 3 of the question ask the question in a negative way, so the higher scores are better for the negative question and are worse for the positive question. There are also 3 questions whether glasses or contacts were needed in the past 7 days with scores of Yes = 1 and No = 2. The results for each question will be summarized separately.
Measured: 3 months follow up
Near Activity Visual Questionnaire (NAVQ)
The Near Activity Visual Questionnaire (NAVQ) is comprised of 10 questions about performing activities without extra reading spectacles. Each question has responses of 0 to 4, with 0 indicating 'No difficulty' and 4 indicating 'Extreme difficulty'. Any 'Not applicable' responses are scored according to the median overall score for the subject. The scores are summed with total score ranging from 0 to 30. Higher scores indicate more difficulty performing specified activities without spectacles.
Measured: 3 months follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2020
- Study start26 Jan 2020
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AmetropiaStudies 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
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Ang, MD, Principal investigator, Asian Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04617080
- Sponsor's protocol ID
- BL1901
- Status last verified
- Feb 2024
- First submitted
- 30 Oct 2020
- Last updated
- 1 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study to Evaluate the Safety and Efficacy of Different Add Powers With a New Presbyopic Lasik Treatment Algorithm
- ClinicalTrials.gov ID
- NCT04617080
- Acronym / sponsor ID
- BL1901
- Conditions
- Ametropia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2020 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 5 Nov 2020 (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.
This is a prospective, comparative, randomized, controlled, open-label, single-surgeon, single-center PMCF clinical study whereby presbyopic patients undergoing refractive surgery will receive a SUPRACOR treatment for the correction in the non-dominant eye and a PROSCAN refractive treatment in the dominant eye to correct for ametropia.
The participants will be randomized to either a SUPRACOR regular (100%) or SUPRACOR strong (130%) treatment with a 1:1 ratio.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SUPRACOR Regular | Active comparator | Procedure: SUPRACOR Regular |
| SUPRACOR Strong | Experimental | Procedure: SUPRACOR Strong |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- presbyopia
- willingness for a refractive presbyopia correction
- signed informed consent form
Key exclusion criteria (1 listed)
- ocular comorbidity
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 |
|---|---|---|
| SUPRACOR RegularSUPRACOR algorithm with regular (100%) ablation profile. SUPRACOR is a presbyopic algorithm that consists of a pre-calculated pulse pattern combined to the refractive pattern to combine near, intermediate and distance vision correction. | Procedure or surgery | SUPRACOR Regular |
| SUPRACOR StrongSUPRACOR algorithm with strong (130%) ablation profile. SUPRACOR is a presbyopic algorithm that consists of a pre-calculated pulse pattern combined to the refractive pattern to combine near, intermediate and distance vision correction. | Procedure or surgery | SUPRACOR Strong |
Primary outcome
Binocular Uncorrected Distance Visual Acuity (UDVA)
Time frame: 3 months follow up
The visual acuity measurements will be assessed using Clinical Trial Suite (M\&S Technologies, Niles, IL, USA) at 4 m in LogMAR scale under photopic light conditions.
13 secondary outcomes
Monocular Uncorrected Distance Visual Acuity (UDVA)
Time frame: 3 months follow up
Monocular Corrected Distance Visual Acuity (CDVA)
Time frame: 3 months follow up
Binocular Corrected Distance Visual Acuity (CDVA)
Time frame: 3 months follow up
Monocular Uncorrected Intermediate Visual Acuity (UIVA)
Time frame: 3 months follow up
Binocular Uncorrected Intermediate Visual Acuity (UIVA)
Time frame: 3 months follow up
Monocular Uncorrected Near Visual Acuity (UNVA)
Time frame: 3 months follow up
Binocular Uncorrected Near Visual Acuity (UNVA)
Time frame: 3 months follow up
Binocular Defocus Curve
Time frame: 3 months follow up
Binocular Contrast sensitivity
Time frame: 3 months follow up
Halo Photic phenomena
Time frame: 3 months follow up
Glare Photic phenomena
Time frame: 3 months follow up
Patient-Reported Spectacle Independence Questionnaire (PRSIQ)
Time frame: 3 months follow up
Near Activity Visual Questionnaire (NAVQ)
Time frame: 3 months follow up
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 1 Mar 2024.
- 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.
Robert Ang, MD principal investigator
Asian Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SUPRACOR Regular and SUPRACOR Strong in people with Ametropia, run by Bausch & Lomb Incorporated at 1 site in Philippines.
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 3 inclusion and 1 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 1 Mar 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 Philippines. 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?
Binocular Uncorrected Distance Visual Acuity (UDVA) (time frame: 3 months follow up). 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 1 Mar 2024.