CataractNCT04126174
Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes
A study testing femtosecond laser system arcuate corneal incision and Manual LRI in people with Cataract, run by Gainesville Eye Associates at 1 site in United States.
Trial summary
This study is designed to compare the effectiveness of LenSx laser arcuate relaxing incisions vs. manual (blade) arcuate relaxing incisions in patients with low, but significant, levels of astigmatism. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- femtosecond laser system arcuate corneal incision and Manual LRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2019to 20 Mar 2021
- 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 40 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 both eyes.
- are willing and able to understand and sign an informed consent;
- are willing and able to attend all study visits;
- are more than 40 years of age, of either gender and any race;
- are presenting for cataract surgery or refractive lens exchange with a desire to reduce astigmatism and will be implanted with a non-toric lens
Show all 21Show fewer
- have good ocular health, with no pathology that compromises visual acuity (outside of residual refractive error and cataract)
- have 0.50 D to 1.75 D of regular corneal astigmatism
- have potential acuity of 20/25 or better
- Are scheduled to have a non-toric monofocal intraocular lens (IOL) (SN60WF) lens implanted in both eyes
- Exclusion Criteria 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. scar, dystrophy, pterygium, moderate-to-severe dry eye)
- Monocular status (e.g. amblyopia)
- Previous radial keratotomy, corneal refractive surgery or other corneal surgery (e.g. corneal transplant, lamellar keratoplasty)
- Previous anterior or posterior chamber surgery (e.g., vitrectomy, laser iridotomy)
- Diabetic retinopathy
- Macular pathology (e.g. age-related macular degeneration, epiretinal membrane)
- 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 post-operative visual acuity.
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Gainesville Eye Associates
Gainesville, Georgia, 30501
About this study
This study is designed to compare the effectiveness of LenSx laser arcuate relaxing incisions vs. manual (blade) arcuate relaxing incisions in patients with low, but significant, levels of astigmatism.
Read the detailed description
This study is a comparative, prospective, randomized contralateral eye study of visual outcomes after LenSx laser arcuate relaxing incisions utilizing the Woodcock nomogram at 90% thickness vs. manual (blade) fixed keratome diamond knife at 600 microns for arcuate relaxing incisions utilizing the Donnenfeld nomogram. Subjects will be assessed pre-operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include measurement of visual acuity, manifest refraction and corneal astigmatism measurement with the Lenstar and slit lamp exam.
- Conditions
- Cataract
- Being tested
- femtosecond laser system arcuate corneal incision, Manual LRI
- Keywords
- astigmatism, limbal relaxing incisions
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
femtosecond laser system arcuate corneal incisionDevice
Also called LRI
Corneal arcuate incision made either with a blade (manual) or femtosecond laser system.
Manual LRIOther
Manual LRI
| Study group | Role | What they receive |
|---|---|---|
| Femtosecond limbal relaxing incision (LRI) | Active comparator | Eyes will be treated with arcuate incisions from a femtosecond laser system. Receives: Device: femtosecond laser system arcuate corneal incision |
| Manual LRI | Active comparator | Eyes will be treated with arcuate incisions completed manually with a blade. Receives: Other: Manual LRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual Refractive Astigmatism
Residual refractive astigmatism measured in diopters
Measured: 3 months
Secondary outcomes (4)
Eyes With Residual Refractive Astigmatism < 0.50 Diopters (D)
The number of eyes with residual refractive astigmatism < 0.50 diopters (D)
Measured: 3 months
Uncorrected Monocular Distance Visual Acuity
Uncorrected monocular distance visual acuity in logMAR
Measured: 3 months
Spherical Equivalent Refraction
Spherical equivalent refraction in diopters
Measured: 3 months
Corneal Astigmatism
Anterior corneal astigmatism
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 posted15 Oct 2019
- Study start15 Oct 2019
- Primary completion20 Mar 2021
- Study completion20 Mar 2021
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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Contralateral eye study
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gainesville Eye Associates
- Sponsor type
- University, hospital or other
- Collaborators
- Science in Vision
- Responsible party
- Sponsor
- Investigators
- Clayton G Blehm, MD, Principal investigator, Gainesville Eye Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04126174
- Sponsor's protocol ID
- CB-19-001
- Status last verified
- Feb 2021
- First submitted
- 11 Oct 2019
- Last updated
- 5 Sep 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 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femtosecond Laser-assisted Arcuate Incisions Versus Manual Arcuate Incisions Outcomes
- ClinicalTrials.gov ID
- NCT04126174
- Acronym / sponsor ID
- CB-19-001
- Conditions
- Cataract
- Keywords
- astigmatism, limbal relaxing incisions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Gainesville Eye AssociatesUniversity, hospital or other
- Collaborators
- Science in Vision
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 20 Mar 2021 (actual)
- Study completion
- 20 Mar 2021 (actual)
- First posted
- 15 Oct 2019 (actual)
- Results
- Posted 5 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to compare the effectiveness of LenSx laser arcuate relaxing incisions vs. manual (blade) arcuate relaxing incisions in patients with low, but significant, levels of astigmatism.
Detailed description
This study is a comparative, prospective, randomized contralateral eye study of visual outcomes after LenSx laser arcuate relaxing incisions utilizing the Woodcock nomogram at 90% thickness vs. manual (blade) fixed keratome diamond knife at 600 microns for arcuate relaxing incisions utilizing the Donnenfeld nomogram. Subjects will be assessed pre-operatively and at 1 day, 1 month and 3 months post-operatively. Clinical evaluations will include measurement of visual acuity, manifest refraction and corneal astigmatism measurement with the Lenstar and slit lamp exam.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Contralateral eye study
| Arm | Type | Receives |
|---|---|---|
| Femtosecond limbal relaxing incision (LRI) | Active comparator | Device: femtosecond laser system arcuate corneal incisionEyes will be treated with arcuate incisions from a femtosecond laser system. |
| Manual LRI | Active comparator | Other: Manual LRIEyes will be treated with arcuate incisions completed manually with a blade. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Note: Ocular criteria must be met in both eyes.
- are willing and able to understand and sign an informed consent;
- are willing and able to attend all study visits;
- are more than 40 years of age, of either gender and any race;
- are presenting for cataract surgery or refractive lens exchange with a desire to reduce astigmatism and will be implanted with a non-toric lens
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| femtosecond laser system arcuate corneal incisionAlso: LRICorneal arcuate incision made either with a blade (manual) or femtosecond laser system. | Device | Femtosecond limbal relaxing incision (LRI) |
| Manual LRIManual LRI | Other | Manual LRI |
Primary outcome
Residual Refractive Astigmatism
Time frame: 3 months
Residual refractive astigmatism measured in diopters
4 secondary outcomes
Eyes With Residual Refractive Astigmatism < 0.50 Diopters (D)
Time frame: 3 months
Uncorrected Monocular Distance Visual Acuity
Time frame: 3 months
Spherical Equivalent Refraction
Time frame: 3 months
Corneal Astigmatism
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 5 Sep 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 femtosecond laser system arcuate corneal incision and Manual LRI 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 21 inclusion and 0 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 5 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 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 5 Sep 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 Astigmatism (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 5 Sep 2021.