AstigmatismNCT05561296
Astigmatism Management With Iris-registration Guided Corneal Relaxing Incisions or Toric IOLs During Cataract Surgery
A study testing Femtosecond laser assisted cataract surgery with astigmatism management in people with Astigmatism and Cataract, run by Kenneth J Rosenthal at 1 site in United States.
Trial summary
Most of the patients presenting for cataract surgery also have pre-existing corneal astigmatism which if left uncorrected can adversely affect visual and refractive outcomes after cataract surgery. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Astigmatism, Cataract
- What is being tested?
- Femtosecond laser assisted cataract surgery with astigmatism management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2022to Dec 2023
- 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 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients desirous of undergoing cataract surgery.
- Pre-existing corneal astigmatism requiring either CRIs or toric IOL implantation.
- Patients in whom iris registration link between Cassini Ambient and Catalys femtosecond laser is successful.
Who cannot join
- Patients will be excluded from participating in the study due to any of the following reasons:
- Insufficient pupil dilation to complete Catalys treatment
- Clinically significant corneal pathology precluding reliable Cassini topographical measurement of any cause
- Preoperative corneal astigmatism greater than 4.00 D, or astigmatism requiring both CRIs and implantation of toric intraocular lens for correction.
- Cassini topographical measurement deemed inconsistent with historical topographies and refractive error based on clinical judgment
- Visually significant ocular surface disease (OSD) precluding reliable measurements and/or anticipated to affect refractive stability
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- Lid position abnormalities that may affect vision
- Moderate or severe stage glaucoma or optic nerve disease, that would interfere with assessment of or achievement of optimal BCVA
- Visually significant macular disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Kenneth J Rosenthal, MD PC
New York, New York, 10128
Danielle Kramer, 212-517-4500, research@eyesurgery.org
Danielle Kramer, BS
About this study
Official title: Safety and Efficacy of Astigmatism Correction by Iris-registration Guided Corneal Relaxing Incisions or Toric IOL Implantation During Femtosecond Laser-assisted Cataract Surgery
Most of the patients presenting for cataract surgery also have pre-existing corneal astigmatism which if left uncorrected can adversely affect visual and refractive outcomes after cataract surgery. Pre-existing astigmatism at the time of cataract surgery can be corrected by either corneal relaxing incisions or implantation of toric IOLs. While the safety and efficacy of these procedures are well established, there are various challenges associated with these techniques that surgeons need to overcome to achieve good outcomes postoperatively.
The use of iris registration technology that automatically compensates for cyclotorsion has the potential to improve the alignment accuracy of CRI or toric IOLs. The Cassini Ambient and Catalys Femtosecond Laser incorporate this technology to help cataract surgeons accurately align toric IOLs on the intended axis of implantation or accurately place CRI on the intended meridian. The present study is aimed at evaluating the efficacy of astigmatism correction during femtosecond laser-assisted cataract surgery with Catalys femtosecond laser. The patients will either undergo iris registration guided CRIs or iris registration guided alignment of toric IOLs.
Read the detailed description
Surgical correction of astigmatism using corneal relaxing incisions or toric IOLs have been widely adopted to correct pre-existing astigmatism in cataract surgery patients. While the safety and efficacy of these procedures are well established, there are various challenges associated with these techniques that surgeons need to overcome to achieve good outcomes postoperatively; for instance, correction of astigmatism either with corneal relaxing incisions (CRIs) or toric IOLs during cataract surgery requires appropriate pre-operative planning based on corneal curvature measurements, biometry, nomogram/IOL selection, accurate marking for the placement of CRI/implantation of toric IOL on the intended axis, intraoperative alignment, cyclotorsion compensation, and postoperative IOL rotation, etc.
The Cassini Ambient and Catalys Femtosecond Laser incorporate this technology to help cataract surgeons accurately align toric IOLs on the intended axis of implantation or accurately place CRI on the intended meridian. This is expected to improve patients' visual functioning and reduce spectacle dependence postoperatively. The Cassini Ambient provides the preoperative anterior and posterior astigmatism with iris registration. The new Catalys Precision Laser System (Johnson \& Johnson Vision) with cOS 6.0 software facilitates direct importation of preoperative data from the Cassini via a wireless connection or USB drive, eliminates the need for manual axis marking as it compares the pre- and intra-operative iris anatomy data and compensates for tilt and rotation so that the laser marks are perfectly aligned to the steep meridian and the target axis. Linking preoperative diagnostic information to the laser minimizes data entry and transcription errors. It also eliminates several steps in the planning process for toric IOLs and CRI, thus improving the overall accuracy of the astigmatism correction procedure and reducing chances for error.
- Conditions
- Astigmatism, Cataract
- Being tested
- Femtosecond laser assisted cataract surgery with astigmatism management
- Keywords
- corneal relaxing incisions, toric IOL, iris registration, femtosecond laser-assisted cataract surgery
- Medical subject headings
- Astigmatism, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femtosecond laser assisted cataract surgery with astigmatism managementProcedure or surgery
The alignment would be guided by preoperatively obtained iris registration using Cassini Ambient. Patients will undergo femtosecond laser-assisted cataract surgery with Catalys femtosecond laser.
| Study group | Role | What they receive |
|---|---|---|
| Astigmatism correction with iris registration guided corneal relaxing incisions | Other | This sub-group will include patients who will undergo femtosecond laser-assisted cataract surgery (Catalys) and astigmatism correction using corneal relaxing incisions and implantation of EyHance IOL. The alignment would be guided by preoperatively obtained iris registration using Cassini Ambient. Receives: Procedure: Femtosecond laser assisted cataract surgery with astigmatism management |
| Astigmatism correction with iris registration guided implantation of toric IOLs | Other | This sub-group will include patients who will undergo femtosecond laser-assisted cataract surgery (Catalys) and astigmatism correction with the implantation of EyHance toric II IOLs. The alignment would be guided by preoperatively obtained iris registration using Cassini Ambient. Receives: Procedure: Femtosecond laser assisted cataract surgery with astigmatism management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean postoperative astigmatism
Mean postoperative astigmatism
Measured: postoperative 3 months
Secondary outcomes (2)
Mean monocular uncorrected distance visual acuity
Postoperative mean monocular uncorrected distance visual acuity
Measured: 3 months postoperatively
Mean monocular corrected distance visual acuity
Postoperative mean monocular corrected distance visual acuity
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AstigmatismStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- This prospective, open-label, single-center, non-randomized, interventional study will include 50 patients who will undergo femtosecond laser-assisted cataract surgery (Catalys) and astigmatism correction by either EyHance toric II IOLs or corneal relaxing incisions and implantation of EyHance IOL. The alignment would be guided by preoperatively obtained iris registration using Cassini Ambient.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kenneth J Rosenthal
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson Surgical Vision, Inc.
- Responsible party
- Sponsor-investigator, Kenneth J Rosenthal, Rosenthal Eye Surgery
- Investigators
- Kenneth J Rosenthal, MD, Principal investigator, Kenneth J Rosenthal, MD PC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05561296
- Sponsor's protocol ID
- KJR/2022/01
- Status last verified
- Sep 2022
- First submitted
- 27 Sep 2022
- Last updated
- 30 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Astigmatism Correction by Iris-registration Guided Corneal Relaxing Incisions or Toric IOL Implantation During Femtosecond Laser-assisted Cataract Surgery
- ClinicalTrials.gov ID
- NCT05561296
- Acronym / sponsor ID
- KJR/2022/01
- Conditions
- Astigmatism, Cataract
- Keywords
- corneal relaxing incisions, toric IOL, iris registration, femtosecond laser-assisted cataract surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kenneth J RosenthalUniversity, hospital or other
- Collaborators
- Johnson & Johnson Surgical Vision, Inc.
- Study start
- Sep 2022 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 30 Sep 2022 (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.
Most of the patients presenting for cataract surgery also have pre-existing corneal astigmatism which if left uncorrected can adversely affect visual and refractive outcomes after cataract surgery. Pre-existing astigmatism at the time of cataract surgery can be corrected by either corneal relaxing incisions or implantation of toric IOLs. While the safety and efficacy of these procedures are well established, there are various challenges associated with these techniques that surgeons need to overcome to achieve good outcomes postoperatively.
The use of iris registration technology that automatically compensates for cyclotorsion has the potential to improve the alignment accuracy of CRI or toric IOLs. The Cassini Ambient and Catalys Femtosecond Laser incorporate this technology to help cataract surgeons accurately align toric IOLs on the intended axis of implantation or accurately place CRI on the intended meridian. The present study is aimed at evaluating the efficacy of astigmatism correction during femtosecond laser-assisted cataract surgery with Catalys femtosecond laser. The patients will either undergo iris registration guided CRIs or iris registration guided alignment of toric IOLs.
Detailed description
Surgical correction of astigmatism using corneal relaxing incisions or toric IOLs have been widely adopted to correct pre-existing astigmatism in cataract surgery patients. While the safety and efficacy of these procedures are well established, there are various challenges associated with these techniques that surgeons need to overcome to achieve good outcomes postoperatively; for instance, correction of astigmatism either with corneal relaxing incisions (CRIs) or toric IOLs during cataract surgery requires appropriate pre-operative planning based on corneal curvature measurements, biometry, nomogram/IOL selection, accurate marking for the placement of CRI/implantation of toric IOL on the intended axis, intraoperative alignment, cyclotorsion compensation, and postoperative IOL rotation, etc.
The Cassini Ambient and Catalys Femtosecond Laser incorporate this technology to help cataract surgeons accurately align toric IOLs on the intended axis of implantation or accurately place CRI on the intended meridian. This is expected to improve patients' visual functioning and reduce spectacle dependence postoperatively. The Cassini Ambient provides the preoperative anterior and posterior astigmatism with iris registration. The new Catalys Precision Laser System (Johnson \& Johnson Vision) with cOS 6.0 software facilitates direct importation of preoperative data from the Cassini via a wireless connection or USB drive, eliminates the need for manual axis marking as it compares the pre- and intra-operative iris anatomy data and compensates for tilt and rotation so that the laser marks are perfectly aligned to the steep meridian and the target axis. Linking preoperative diagnostic information to the laser minimizes data entry and transcription errors. It also eliminates several steps in the planning process for toric IOLs and CRI, thus improving the overall accuracy of the astigmatism correction procedure and reducing chances for error.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This prospective, open-label, single-center, non-randomized, interventional study will include 50 patients who will undergo femtosecond laser-assisted cataract surgery (Catalys) and astigmatism correction by either EyHance toric II IOLs or corneal relaxing incisions and implantation of EyHance IOL. The alignment would be guided by preoperatively obtained iris registration using Cassini Ambient.
| Arm | Type | Receives |
|---|---|---|
| Astigmatism correction with iris registration guided corneal relaxing incisions | Other | Procedure: Femtosecond laser assisted cataract surgery with astigmatism managementThis sub-group will include patients who will undergo femtosecond laser-assisted cataract surgery (Catalys) and astigmatism correction using corneal relaxing incisions and implantation of EyHance IOL. The alignment would be guided by preoperatively obtained iris registration using Cassini Ambient. |
| Astigmatism correction with iris registration guided implantation of toric IOLs | Other | Procedure: Femtosecond laser assisted cataract surgery with astigmatism managementThis sub-group will include patients who will undergo femtosecond laser-assisted cataract surgery (Catalys) and astigmatism correction with the implantation of EyHance toric II IOLs. The alignment would be guided by preoperatively obtained iris registration using Cassini Ambient. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients desirous of undergoing cataract surgery.
- Pre-existing corneal astigmatism requiring either CRIs or toric IOL implantation.
- Patients in whom iris registration link between Cassini Ambient and Catalys femtosecond laser is successful.
Key exclusion criteria (9 listed)
- Patients will be excluded from participating in the study due to any of the following reasons:
- Insufficient pupil dilation to complete Catalys treatment
- Clinically significant corneal pathology precluding reliable Cassini topographical measurement of any cause
- Preoperative corneal astigmatism greater than 4.00 D, or astigmatism requiring both CRIs and implantation of toric intraocular lens for correction.
- Cassini topographical measurement deemed inconsistent with historical topographies and refractive error based on clinical judgment
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 assisted cataract surgery with astigmatism managementThe alignment would be guided by preoperatively obtained iris registration using Cassini Ambient. Patients will undergo femtosecond laser-assisted cataract surgery with Catalys femtosecond laser. | Procedure or surgery | Astigmatism correction with iris registration guided corneal relaxing incisions, Astigmatism correction with iris registration guided implantation of toric IOLs |
Primary outcome
Mean postoperative astigmatism
Time frame: postoperative 3 months
Mean postoperative astigmatism
2 secondary outcomes
Mean monocular uncorrected distance visual acuity
Time frame: 3 months postoperatively
Mean monocular corrected distance visual acuity
Time frame: 3 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2022.
- 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.
Kenneth J Rosenthal, MD principal investigator
Kenneth J Rosenthal, MD PC
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 assisted cataract surgery with astigmatism management in people with Astigmatism and Cataract, run by Kenneth J Rosenthal 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 3 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: status not confirmed, as of the sponsor's last update on 30 Sep 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kenneth J Rosenthal, MD (212 517-4500, research@eyesurgery.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean postoperative astigmatism (time frame: postoperative 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 30 Sep 2022.