CataractNCT03856944
Evaluating Refractive and Visual Outcomes With the Alcon Toric ReSTOR +2.5 and +3.0 Models
A study testing ReSTOR Toric in people with Cataract, run by Gainesville Eye Associates at 1 site in United States.
Trial summary
The study will evaluate visual acuity and visual function with a 'blended' ReSTOR Toric intraocular lens (IOL) implantation after cataract surgery. Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- ReSTOR Toric
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2018to 18 Nov 2019
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects are eligible for the study if they meet the following criteria:
- Note: Ocular criteria must be met in the eligible eye.
- Bilateral visually-significant cataracts
- Willing and able to provide written informed consent for participation in the study.
- Willing and able to comply with scheduled visits and other study procedures.
- have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)
- Regular corneal astigmatism of 1.00D to 2.50D in both eyes
- Potential postoperative acuity of 20/25 or better
Who cannot join
- If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- Irregular astigmatism (e.g. keratoconus)
- Corneal pathology (e.g. opacities, epithelial basement membrane dystrophy (EBMD), Fuch's dystrophy, etc.)
- Monocular status (e.g. amblyopia)
- Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, Descemet Stripping Automated Endothelial Keratoplasty (DSAEK), lamellar keratoplasty)
- Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
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- Moderate-to-advanced glaucoma
- Strabismus
- Use of arcuate incisions for astigmatism management at the time of surgery
- Diabetic retinopathy
- Macular pathology (e.g. age-related macular degeneration, epiretinal membrane, etc.)
- History of retinal detachment
- Subjects who have an acute or chronic disease or illness that would confound the results of this investigation (e.g., immunocompromised, connective tissue disease, clinically significant atopic disease, diabetes, and any other such disease or illness), that are known to affect postoperative visual acuity.
- Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
- The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
- Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gainesville Eye Associates
Gainesville, Georgia, 30501
About this study
The study will evaluate visual acuity and visual function with a 'blended' ReSTOR Toric intraocular lens (IOL) implantation after cataract surgery.
Read the detailed description
The objective is to provide a normative standard for refractive and visual outcomes in eyes with significant corneal astigmatism undergoing cataract surgery with the Alcon Toric ReSTOR lens. Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye.
- Conditions
- Cataract
- Being tested
- ReSTOR Toric
- Keywords
- Astigmatism, intraocular lens, multifocal
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReSTOR ToricDevice
Also called ReSTOR +2.5 Toric, ReSTOR +3.0 Toric
ReSTOR Toric bilateral IOL implantation
| Study group | Role | What they receive |
|---|---|---|
| ReSTOR Toric | Experimental | Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. Receives: Device: ReSTOR Toric |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual Refractive Cylinder
Manifest postoperative refractive cylinder (measured in diopters, with a phoropter or trial lens set) after cataract surgery and IOL implantation
Measured: 3 months
Secondary outcomes (16)
Monocular Uncorrected Near Visual Acuity
Monocular uncorrected near visual acuity measuring in logMAR
Measured: 3 months
Monocular Uncorrected Distance Visual Acuity
Monocular uncorrected distance visual acuity measured in logMAR notation
Measured: 3 months
Monocular Uncorrected Intermediate Visual Acuity
Monocular Uncorrected intermediate visual acuity measured in logMAR notation (log of the minimum angle of resolution)
Measured: 3 months
Monocular Best Corrected Distance Visual Acuity
Monocular best corrected distance visual acuity measured in logMAR notation
Measured: 3 months
Monocular Best Distance-corrected Intermediate Visual Acuity
Monocular best distance-corrected intermediate visual acuity in logMAR notation
Measured: 3 months
Monocular Best Distance-corrected Near Visual Acuity
Monocular best distance-corrected near visual acuity measured in logMAR notation
Measured: 3 months
Binocular Uncorrected Near Visual Acuity
Binocular uncorrected near (40cm) visual acuity measured in logMAR notation
Measured: 3 months
Binocular Uncorrected Distance Visual Acuity
Binocular uncorrected distance visual acuity measured in logMAR notation
Measured: 3 months
Binocular Uncorrected Intermediate Visual Acuity
Binocular uncorrected intermediate (60cm) visual acuity
Measured: 3 months
Binocular Best-corrected Distance Visual Acuity
Binocular best-corrected distance visual acuity measured in logMAR notation
Measured: 3 months
Binocular Best Distance-corrected Intermediate Visual Acuity
Binocular best distance-corrected intermediate (60cm) visual acuity
Measured: 3 months
Binocular Best Distance-corrected Near Visual Acuity
Binocular best distance-corrected near (40cm) visual acuity
Measured: 3 months
IOL Orientation
Postoperative orientation changes with the Toric ReSTOR IOL up to 3 months after surgery will be measured by determining the angle of orientation of the IOL in degrees (0-180) using a slit lamp.
Measured: 3 months
Binocular Best Distance-corrected Defocus Curve
Binocular best distance-corrected defocus curve.
Measured: 3 months
Binocular Uncorrected Defocus Curve.
Binocular uncorrected defocus curve, from +1.0D to -4.00D in 0.50D increments
Measured: 3 months
Subjective Visual Quality
Quality of vision, measured with a subjective questionnaire (Q of V). Frequency, Severity and "Degree of Bother" aggregate statistics. Scored on a Rasch scale (0-100) where lower is better.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start5 Oct 2018
- Primary completion18 Nov 2019
- Study completion18 Nov 2019
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 CataractStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a prospective, single center, open clinical trial to collect normative performance data.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gainesville Eye Associates
- Sponsor type
- University, hospital or other
- Collaborators
- SiV Consulting
- Responsible party
- Principal investigator, Clayton Blehm, MD, Gainesville Eye Associates
- Investigators
- Clayton G Blehm, MD, Principal investigator, Gainesville Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856944
- Sponsor's protocol ID
- CB-18-001
- Status last verified
- Jul 2021
- First submitted
- 4 Oct 2018
- Last updated
- 6 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Refractive and Visual Outcomes With the Alcon Toric ReSTOR +2.5 and +3.0 Models
- ClinicalTrials.gov ID
- NCT03856944
- Acronym / sponsor ID
- CB-18-001
- Conditions
- Cataract
- Keywords
- Astigmatism, intraocular lens, multifocal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Gainesville Eye AssociatesUniversity, hospital or other
- Collaborators
- SiV Consulting
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 18 Nov 2019 (actual)
- Study completion
- 18 Nov 2019 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Posted 6 Aug 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate visual acuity and visual function with a 'blended' ReSTOR Toric intraocular lens (IOL) implantation after cataract surgery.
Detailed description
The objective is to provide a normative standard for refractive and visual outcomes in eyes with significant corneal astigmatism undergoing cataract surgery with the Alcon Toric ReSTOR lens. Patients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a prospective, single center, open clinical trial to collect normative performance data.
| Arm | Type | Receives |
|---|---|---|
| ReSTOR Toric | Experimental | Device: ReSTOR ToricPatients will be bilaterally implanted, with the Toric ReSTOR +2.5D model implanted in the dominant eye and the Toric ReSTOR +3.0D model implanted in the non-dominant eye. Patients will self-select for multifocal implantation. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects are eligible for the study if they meet the following criteria:
- Note: Ocular criteria must be met in the eligible eye.
- Bilateral visually-significant cataracts
- Willing and able to provide written informed consent for participation in the study.
- Willing and able to comply with scheduled visits and other study procedures.
Key exclusion criteria (16 listed)
- If any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study.
- The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
- Pregnancy has a known effect on the stability of refractions and visual acuity. As such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
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 |
|---|---|---|
| ReSTOR ToricAlso: ReSTOR +2.5 Toric, ReSTOR +3.0 ToricReSTOR Toric bilateral IOL implantation | Device | ReSTOR Toric |
Primary outcome
Residual Refractive Cylinder
Time frame: 3 months
Manifest postoperative refractive cylinder (measured in diopters, with a phoropter or trial lens set) after cataract surgery and IOL implantation
16 secondary outcomes
Monocular Uncorrected Near Visual Acuity
Time frame: 3 months
Monocular Uncorrected Distance Visual Acuity
Time frame: 3 months
Monocular Uncorrected Intermediate Visual Acuity
Time frame: 3 months
Monocular Best Corrected Distance Visual Acuity
Time frame: 3 months
Monocular Best Distance-corrected Intermediate Visual Acuity
Time frame: 3 months
Monocular Best Distance-corrected Near Visual Acuity
Time frame: 3 months
Binocular Uncorrected Near Visual Acuity
Time frame: 3 months
Binocular Uncorrected Distance Visual Acuity
Time frame: 3 months
Binocular Uncorrected Intermediate Visual Acuity
Time frame: 3 months
Binocular Best-corrected Distance Visual Acuity
Time frame: 3 months
Binocular Best Distance-corrected Intermediate Visual Acuity
Time frame: 3 months
Binocular Best Distance-corrected Near Visual Acuity
Time frame: 3 months
IOL Orientation
Time frame: 3 months
Binocular Best Distance-corrected Defocus Curve
Time frame: 3 months
Binocular Uncorrected Defocus Curve.
Time frame: 3 months
Subjective Visual Quality
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Clayton G Blehm, MD principal investigator
Gainesville Eye Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReSTOR Toric in people with Cataract, run by Gainesville Eye Associates 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 16 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 6 Aug 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 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 6 Aug 2021). 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?
Residual Refractive Cylinder (time frame: 3 months). 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 6 Aug 2021.