AstigmatismTA OS 2025-1NCT07007897
Observational Study - TA- 2025-1
An observational study of Astigmatism, run by Haag-Streit AG at 2 sites in United States.
Trial summary
This multi-centric, prospective observational study collects biometric datasets as well as associated video recordings of the surgical procedure. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Astigmatism
- What is being tested?
- Optical Biometry and Cataract Surgery
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Apr 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any individual over the age of 21 seeking elective cataract surgery at the study sites.
Who may be able to join
- diagnosed with cataracts (any grade),
- Seeking cataract treatment,
- willing to provide informed consent.
Who cannot join
- Active ocular infections or trauma.
- Poor fixation ability (e.g., severe nystagmus).
- Prior intraocular surgery.
- Seeking toric IOL implantation requiring ink marking.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
Pacific Clear Vision Institute
Eugene, Oregon, 97401
East Valley Ophthalmology
Mesa, Arizona, 85206
About this study
Official title: Toric Alignment Observational Study 2025-1
This multi-centric, prospective observational study collects biometric datasets as well as associated video recordings of the surgical procedure.
- Conditions
- Astigmatism
- Being tested
- Optical Biometry, Cataract Surgery
- Medical subject headings
- Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical BiometryDevice
Biometric measurements of the eye used for surgical planning will be obtained.
Cataract SurgeryProcedure or surgery
A video recording of the surgical procedure will be obtained.
What is being measured
The primary outcome is the main question the study is designed to answer.
Biometric data
collect anonymised biometric data from patients undergoing elective cataract surgery
Measured: one-time measurement before surgery
Video recording
collect anonymised video recording of surgical procedure from patients undergoing elective cataract surgery
Measured: during the surgical procedure
Secondary outcomes (1)
Software algorith
Verification of software algorithms that use the biometric data to analyse the video recordings.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Apr 2025
- Primary completion30 Jul 2025 (estimated)
- Study completion31 Dec 2025 (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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haag-Streit AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan Rübel, PhD, Study chair, Haag-StreitJulian V Kool van Langenberghe, ing, Study director, Haag-Streit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07007897
- Sponsor's protocol ID
- 9360002
- Acronym
- TA OS 2025-1
- Status last verified
- Jun 2025
- First submitted
- 17 Mar 2025
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- 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 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toric Alignment Observational Study 2025-1
- ClinicalTrials.gov ID
- NCT07007897
- Acronym / sponsor ID
- TA OS 2025-1 / 9360002
- Conditions
- Astigmatism
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Haag-Streit AGIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Jun 2025 (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 multi-centric, prospective observational study collects biometric datasets as well as associated video recordings of the surgical procedure.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any individual over the age of 21 seeking elective cataract surgery at the study sites.
Key inclusion criteria (3 listed)
- diagnosed with cataracts (any grade),
- Seeking cataract treatment,
- willing to provide informed consent.
Key exclusion criteria (4 listed)
- Active ocular infections or trauma.
- Poor fixation ability (e.g., severe nystagmus).
- Prior intraocular surgery.
- Seeking toric IOL implantation requiring ink marking.
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 |
|---|---|---|
| Optical BiometryBiometric measurements of the eye used for surgical planning will be obtained. | Device | – |
| Cataract SurgeryA video recording of the surgical procedure will be obtained. | Procedure or surgery | – |
Primary outcome
Biometric data
Time frame: one-time measurement before surgery
collect anonymised biometric data from patients undergoing elective cataract surgery
Video recording
Time frame: during the surgical procedure
collect anonymised video recording of surgical procedure from patients undergoing elective cataract surgery
1 secondary outcome
Software algorith
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- 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.
Jan Rübel, PhD study chair
Haag-Streit
Julian V Kool van Langenberghe, ing study director
Haag-Streit
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, run by Haag-Streit AG at 2 sites 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 4 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: enrolling by invitation, as of the sponsor's last update on 6 Jun 2025. 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 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?
This study is still under way. Results are not available in the source record yet.
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?
Biometric data (time frame: one-time measurement before surgery). 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 6 Jun 2025; AzTrials last refreshed its copy on 26 Oct 2026.