CataractARCUATASNCT05053620
Astigmatism Correction With Intrastromal Arcuate Incisions in Eyes Undergoing Cataract Surgery With Femtosecond Laser Using the Cassini Ambient With Iris Registration (ARCUATAS)
An observational study of Cataract and Astigmatism, run by OFTALVIST (Oftalmología Vistahermosa S.L) at 1 site in Spain.
Trial summary
This is an observational, prospective follow-up post-marketing study of CE marked medical devices aimed at treating astigmatism in patients with cataracts. The main objective is to evaluate the response of the intrastromal arcuate incisions procedure for the correction of low corneal astigmatism with the Catalys… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Astigmatism
- What is being tested?
- Calculation of the arcuate intrasomal incisions
- Type of treatment
- Medical device
- How many people
- 22 participants
- Where
- 1 siteSpain
- Study dates
- 19 Oct 2021to 18 Apr 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are already going to undergo conventional cataract surgery by phacoemulsification in which there is low corneal astigmatism (up to 1.25 D) and it is corrected by means of arcuate intrastromal incisions with femtosecond laser following routine clinical practice.
Who may be able to join
- Patients who are going to undergo cataract surgery.
- Low corneal astigmatism, between 0.50D and 1.25D.
Who cannot join
- Previous corneal surgery.
- Keratoconus.
- Corneal scars
- Pterygium
- Glaucoma
Trial locations and contacts
1 site in 1 country.
About this study
This is an observational, prospective follow-up post-marketing study of CE marked medical devices aimed at treating astigmatism in patients with cataracts. The main objective is to evaluate the response of the intrastromal arcuate incisions procedure for the correction of low corneal astigmatism with the Catalys femtosecond laser using the Cassini Ambient equipment with iris registration in cataract surgery.
Read the detailed description
All patients participating in the study will undergo femtosecond laser treatment for the correction of astigmatism through arcuate intrastromal incisions with the Catalys laser (Johnson \& Johnson, USA, CE marked). The calculation of intrastromal arcuate incisions will be carried out using the following nomogram indicated on the laser: 9.0 mm optical zone and symmetrical incisions of 50 degrees for 0.50D, 55 degrees for 0.75D, 60 degrees for 1.00D and 65 degrees for 1.25D of corneal astigmatism. After the incisions, conventional cataract surgery will be performed using the Centurion phacoemulsifier equipment (Alcon, USA, with CE marking) in the ZCB00 monofocal intraocular lens (IOL) implant (Johnson \& Johnson, USA, with CE marking). All patients will be treated according to standard clinical practice.
A preoperative and postoperative evaluation will be carried out one month and four months after the intervention where the following tests will be performed: refraction, corneal topography with the Cassini Ambient equipment (Cassini Technologies, The Netherlands, with CE marking), measurement of visual acuity with and without correction, slit lamp examination and ocular biometry using the IOLMaster 700 non-contact optical biometer (Carl Zeiss, Germany, CE marked).
- Conditions
- Cataract, Astigmatism
- Being tested
- Calculation of the arcuate intrasomal 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.
Calculation of the arcuate intrasomal incisionsDevice
All patients participating in the study will undergo femtosecond laser treatment for the correction of astigmatism through arcuate intrastromal incisions with the Catalys laser (Johnson \& Johnson, USA, CE marked). The calculation of intrastromal arcuate incisions will be carried out using the following nomogram indicated on the laser: 9.0 mm optical zone and symmetrical incisions of 50 degrees for 0.50D, 55 degrees for 0.75D, 60 degrees for 1.00D and 65 degrees for 1.25D of corneal astigmatism. After the incisions, conventional cataract surgery will be performed using the Centurion phacoemulsifier equipment (Alcon, USA, with CE marking) in the ZCB00 monofocal intraocular lens (IOL) implant (Johnson \& Johnson, USA, with CE marking). All patients will be treated according to standard clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | All patients. Receives: Device: Calculation of the arcuate intrasomal incisions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment
Evaluation of the response to the procedure
Measured: 4 months after the procedure
Secondary outcomes (2)
Evaluation of the visual acuity
Evaluation of the visual acuity
Measured: 4 months after the procedure
Examination of the arcuate incisions
Examination of the arcuate incisions using a slit amp
Measured: 4 months after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start19 Oct 2021
- Primary completion18 Apr 2023
- Study completion18 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- OFTALVIST (Oftalmología Vistahermosa S.L)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Surgical Vision, Inc.
- Responsible party
- Sponsor
- Investigators
- Pedro Tañá Rivero, Doctor, Principal investigator, OFTALVIST (Oftalmología Vistahermosa S.L)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053620
- Sponsor's protocol ID
- ARCUATAS
- Acronym
- ARCUATAS
- Status last verified
- May 2023
- First submitted
- 8 Sep 2021
- Last updated
- 22 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Astigmatism Correction With Intrastromal Arcuate Incisions in Eyes Undergoing Cataract Surgery With Femtosecond Laser Using the Cassini Ambient With Iris Registration (ARCUATAS)
- ClinicalTrials.gov ID
- NCT05053620
- Acronym / sponsor ID
- ARCUATAS / ARCUATAS
- Conditions
- Cataract, Astigmatism
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- OFTALVIST (Oftalmología Vistahermosa S.L)Industry (pharma, biotech, devices)
- Collaborators
- Johnson & Johnson Surgical Vision, Inc.
- Study start
- 19 Oct 2021 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 18 Apr 2023 (actual)
- First posted
- 22 Sep 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.
This is an observational, prospective follow-up post-marketing study of CE marked medical devices aimed at treating astigmatism in patients with cataracts. The main objective is to evaluate the response of the intrastromal arcuate incisions procedure for the correction of low corneal astigmatism with the Catalys femtosecond laser using the Cassini Ambient equipment with iris registration in cataract surgery.
Detailed description
All patients participating in the study will undergo femtosecond laser treatment for the correction of astigmatism through arcuate intrastromal incisions with the Catalys laser (Johnson \& Johnson, USA, CE marked). The calculation of intrastromal arcuate incisions will be carried out using the following nomogram indicated on the laser: 9.0 mm optical zone and symmetrical incisions of 50 degrees for 0.50D, 55 degrees for 0.75D, 60 degrees for 1.00D and 65 degrees for 1.25D of corneal astigmatism. After the incisions, conventional cataract surgery will be performed using the Centurion phacoemulsifier equipment (Alcon, USA, with CE marking) in the ZCB00 monofocal intraocular lens (IOL) implant (Johnson \& Johnson, USA, with CE marking). All patients will be treated according to standard clinical practice.
A preoperative and postoperative evaluation will be carried out one month and four months after the intervention where the following tests will be performed: refraction, corneal topography with the Cassini Ambient equipment (Cassini Technologies, The Netherlands, with CE marking), measurement of visual acuity with and without correction, slit lamp examination and ocular biometry using the IOLMaster 700 non-contact optical biometer (Carl Zeiss, Germany, CE marked).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | – | Device: Calculation of the arcuate intrasomal incisionsAll patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are already going to undergo conventional cataract surgery by phacoemulsification in which there is low corneal astigmatism (up to 1.25 D) and it is corrected by means of arcuate intrastromal incisions with femtosecond laser following routine clinical practice.
Key inclusion criteria (2 listed)
- Patients who are going to undergo cataract surgery.
- Low corneal astigmatism, between 0.50D and 1.25D.
Key exclusion criteria (5 listed)
- Previous corneal surgery.
- Keratoconus.
- Corneal scars
- Pterygium
- Glaucoma
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 |
|---|---|---|
| Calculation of the arcuate intrasomal incisionsAll patients participating in the study will undergo femtosecond laser treatment for the correction of astigmatism through arcuate intrastromal incisions with the Catalys laser (Johnson \& Johnson, USA, CE marked). The calculation of intrastromal arcuate incisions will be carried out using the following nomogram indicated on the laser: 9.0 mm optical zone and symmetrical incisions of 50 degrees for 0.50D, 55 degrees for 0.75D, 60 degrees for 1.00D and 65 degrees for 1.25D of corneal astigmatism. After the incisions, conventional cataract surgery will be performed using the Centurion phacoemulsifier equipment (Alcon, USA, with CE marking) in the ZCB00 monofocal intraocular lens (IOL) implant (Johnson \& Johnson, USA, with CE marking). All patients will be treated according to standard clinical practice. | Device | Single arm |
Primary outcome
Response to treatment
Time frame: 4 months after the procedure
Evaluation of the response to the procedure
2 secondary outcomes
Evaluation of the visual acuity
Time frame: 4 months after the procedure
Examination of the arcuate incisions
Time frame: 4 months after the procedure
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 22 May 2023.
- Individual participant dataSharing planned: No
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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.
Pedro Tañá Rivero, Doctor principal investigator
OFTALVIST (Oftalmología Vistahermosa S.L)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Astigmatism, run by OFTALVIST (Oftalmología Vistahermosa S.L) at 1 site in Spain.
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 2 inclusion and 5 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 22 May 2023. 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 Spain. 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?
Response to treatment (time frame: 4 months after the procedure). 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 22 May 2023.