AstigmatismHIPER-AT-TORBINCT05058274
Clinical Results of a Monofocal Aspheric Bitoric Intraocular Lens With Plate Haptics in Hyperopic Eyes (HIPER-AT-TORBI)
An observational study of Astigmatism and Far Sightedness, run by OFTALVIST (Oftalmología Vistahermosa S.L) at 2 sites in Spain.
Trial summary
Observational post-marketing study with prospective follow-up of CE marked medical devices aimed at the treatment of hyperopia and astigmatism in patients with cataract. The objective is to evaluate the clinical results of the implantation of the monofocal aspheric bitoric intraocular lens (IOL) with AT-TORBI 709… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Astigmatism, Far Sightedness, Cataracts
- What is being tested?
- Implant of the AT-TORBI 709 lens
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 2 sitesSpain
- Study dates
- 3 Nov 2021to 21 Feb 2024
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are going to undergo conventional cataract surgery by phacoemulsification following regular clinical practice and present hyperopia with astigmatism.
Who may be able to join
- Patients of 50 years of age or older to undergo cataract surgery with phacoemulsification
- Patient who signs the informed consent.
- Regular corneal astigmatism between 1.0D and 4.0D.
- IOL power between 21D and 26D
- Target-target distance measured with the IOLMaster 700 biometer (Carl Zeiss Meditec AG) greater than 11.6 mm.
- Patients with hyperopia between 1.0D and 4.0D.
Who cannot join
- Patients who do not provide informed consent
- Patients who do not understand the study procedure
- Previous corneal surgery.
- Irregular cornea (eg keratoconus)
- myopic patients
- Eye abnormalities or pathologies that could reduce the visual function or stability of the IOL (eg severe amblyopia or macular degeneration)
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
OFTALVIST (Oftalmología Vistahermosa S.L.)
Alicante, 03015
OFTALVIST (Oftalmología Vistahermosa S.L.)
Valencia, 46004
About this study
Observational post-marketing study with prospective follow-up of CE marked medical devices aimed at the treatment of hyperopia and astigmatism in patients with cataract. The objective is to evaluate the clinical results of the implantation of the monofocal aspheric bitoric intraocular lens (IOL) with AT-TORBI 709 plate haptics in cataract surgery of hyperopic eyes with astigmatism.
Read the detailed description
All patients participating in the study will have the intraocular lens (IOL) AT TORBI 709 implanted from Carl Zeiss Meditec AG, Jena, Germany, with CE marking. All patients will be treated according to standard clinical practice. A preoperative and postoperative evaluation will be carried out one month, six and twelve months after the intervention where the following tests will be performed: refraction, corneal topography, measurement of visual acuity with and without correction, slit lamp examination, eye biometry using the IOLMaster 700 Carl Zeiss Meditec AG, Jena, Germany, CE marked optical non-contact biometer, contrast sensitivity with the CC-100 screen (Topcon Europe, The Netherlands), and the Catquest-9SF (European Registry of Quality Outcomes for Cataract and Refractive Surgery, founded by the European Society of Cataract and Refractive Surgeons). The sponsor has received an unrestricted research grant by Zeiss.
- Conditions
- Astigmatism, Far Sightedness, Cataracts
- Being tested
- Implant of the AT-TORBI 709 lens
- Medical subject headings
- Astigmatism, Hyperopia, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implant of the AT-TORBI 709 lensDevice
Implant of the AT-TORBI 709 lens
| Study group | Role | What they receive |
|---|---|---|
| Single arm | All participants Receives: Device: Implant of the AT-TORBI 709 lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the refractive error
Measurement of the refractive error (equivalent spherical error, the refractive cylinder and the astigmatism vectors (J0 and J45) )
Measured: 12 months
Measurement of the rotational stability
Measurement of the rotational stability
Measured: 12 months
Secondary outcomes (6)
Measure of visual acuity
Measurement of visual acuity
Measured: 12 months
Measure of corneal topography
Measure of corneal topography
Measured: 12 months
Measure of ocular biometry
Measure of ocular biometry
Measured: 12 months
Measure of contrast sensitivity
Measure of contrast sensitivity
Measured: 12 months
Satisfaction questionaire
For several questions percentage of respondants answering each of five possible provided answers ranging progressively from strong disatisfaction to strong satisfaction (1-4) as well as an answer for those patients who cannot decide (5)
Measured: 12 months
Slit lamp examination
Slit lamp examination
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start3 Nov 2021
- Primary completion21 Feb 2024
- Study completion21 Feb 2024
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- OFTALVIST (Oftalmología Vistahermosa S.L)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Carl Zeiss Meditec AG
- Responsible party
- Sponsor
- Investigators
- Pedro Tañá Rivero, Doctor, Principal investigator, OFTALVIST (Oftalmología Vistahermosa S.L)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058274
- Sponsor's protocol ID
- HIPER-AT-TORBI
- Acronym
- HIPER-AT-TORBI
- Status last verified
- Mar 2024
- First submitted
- 8 Sep 2021
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided: A publication summarizing the results of the study will be made public after the study termination.
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Results of a Monofocal Aspheric Bitoric Intraocular Lens With Plate Haptics in Hyperopic Eyes (HIPER-AT-TORBI)
- ClinicalTrials.gov ID
- NCT05058274
- Acronym / sponsor ID
- HIPER-AT-TORBI / HIPER-AT-TORBI
- Conditions
- Astigmatism, Far Sightedness, Cataracts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- OFTALVIST (Oftalmología Vistahermosa S.L)Industry (pharma, biotech, devices)
- Collaborators
- Carl Zeiss Meditec AG
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 21 Feb 2024 (actual)
- First posted
- 27 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.
Observational post-marketing study with prospective follow-up of CE marked medical devices aimed at the treatment of hyperopia and astigmatism in patients with cataract. The objective is to evaluate the clinical results of the implantation of the monofocal aspheric bitoric intraocular lens (IOL) with AT-TORBI 709 plate haptics in cataract surgery of hyperopic eyes with astigmatism.
Detailed description
All patients participating in the study will have the intraocular lens (IOL) AT TORBI 709 implanted from Carl Zeiss Meditec AG, Jena, Germany, with CE marking. All patients will be treated according to standard clinical practice. A preoperative and postoperative evaluation will be carried out one month, six and twelve months after the intervention where the following tests will be performed: refraction, corneal topography, measurement of visual acuity with and without correction, slit lamp examination, eye biometry using the IOLMaster 700 Carl Zeiss Meditec AG, Jena, Germany, CE marked optical non-contact biometer, contrast sensitivity with the CC-100 screen (Topcon Europe, The Netherlands), and the Catquest-9SF (European Registry of Quality Outcomes for Cataract and Refractive Surgery, founded by the European Society of Cataract and Refractive Surgeons). The sponsor has received an unrestricted research grant by Zeiss.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | – | Device: Implant of the AT-TORBI 709 lensAll participants |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are going to undergo conventional cataract surgery by phacoemulsification following regular clinical practice and present hyperopia with astigmatism.
Key inclusion criteria (6 listed)
- Patients of 50 years of age or older to undergo cataract surgery with phacoemulsification
- Patient who signs the informed consent.
- Regular corneal astigmatism between 1.0D and 4.0D.
- IOL power between 21D and 26D
- Target-target distance measured with the IOLMaster 700 biometer (Carl Zeiss Meditec AG) greater than 11.6 mm.
Key exclusion criteria (6 listed)
- Patients who do not provide informed consent
- Patients who do not understand the study procedure
- Previous corneal surgery.
- Irregular cornea (eg keratoconus)
- myopic patients
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 |
|---|---|---|
| Implant of the AT-TORBI 709 lensImplant of the AT-TORBI 709 lens | Device | Single arm |
Primary outcome
Measurement of the refractive error
Time frame: 12 months
Measurement of the refractive error (equivalent spherical error, the refractive cylinder and the astigmatism vectors (J0 and J45) )
Measurement of the rotational stability
Time frame: 12 months
Measurement of the rotational stability
6 secondary outcomes
Measure of visual acuity
Time frame: 12 months
Measure of corneal topography
Time frame: 12 months
Measure of ocular biometry
Time frame: 12 months
Measure of contrast sensitivity
Time frame: 12 months
Satisfaction questionaire
Time frame: 12 months
Slit lamp examination
Time frame: 12 months
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 Mar 2024.
- Individual participant dataSharing planned: Undecided. A publication summarizing the results of the study will be made public after the study termination.
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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.
Pedro Tañá Rivero, Doctor principal investigator
OFTALVIST (Oftalmología Vistahermosa S.L)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Astigmatism and Far Sightedness, run by OFTALVIST (Oftalmología Vistahermosa S.L) at 2 sites 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 6 inclusion and 6 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 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 2 sites 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?
Measurement of the refractive error (time frame: 12 months). The study lists 2 primary outcomes in all. 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 Mar 2024.