Cataract3 TORIC ROTATENCT07453992
Postoperative Rotational Dynamics of Three Toric Intraocular Lens Designs
A study testing TECNIS Toric II (ZCU), AcrySof IQ Toric and AT TORBI 709M in people with Cataract, run by Jin Yang at 1 site in China.
Trial summary
This prospective comparative cohort study evaluates and compares postoperative rotational stability and time-course dynamics of three commercially available toric intraocular lenses (TECNIS Toric II [ZCU], AcrySof IQ Toric, and AT TORBI 709M) after phacoemulsification cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- TECNIS Toric II (ZCU), AcrySof IQ Toric and AT TORBI 709M
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2025to 31 Dec 2030
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 years or older with age-related cataract scheduled for phacoemulsification cataract surgery.
- Presence of regular corneal astigmatism requiring toric intraocular lens implantation.
- Eligible for implantation of one of the three study toric intraocular lenses based on preoperative evaluation.
- Ability to understand the study procedures and provide written informed consent.
Who cannot join
- History of prior ocular surgery in the study eye.
- History of ocular trauma in the study eye.
- Irregular corneal astigmatism or corneal pathology affecting reliable biometric measurement.
- Intraoperative complications, including anterior capsular tear or posterior capsular rupture.
- Inadequate pupillary dilation during surgery or postoperative examinations.
- Evidence of zonular weakness, zonular dialysis, or lens subluxation.
- Active ocular infection or inflammation.
- Any other ocular or systemic condition judged by the investigator to potentially affect intraocular lens stability or study outcomes.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Eye and ENT hospital of Fudan University
Shanghai, Shanghai Municipality, 200000
Xuanqiao Lin, 15088920668, 1532483480@qq.com
About this study
Official title: Postoperative Rotational Dynamics of Different Toric Intraocular Lens Designs
This prospective comparative cohort study evaluates and compares postoperative rotational stability and time-course dynamics of three commercially available toric intraocular lenses (TECNIS Toric II [ZCU], AcrySof IQ Toric, and AT TORBI 709M) after phacoemulsification cataract surgery. Rotation is quantified by registering postoperative retroillumination photographs to the end-of-surgery baseline using iris/scleral landmarks, with follow-up at postoperative day 1, day 3, week 1, week 2, month 1, and month 3. Associations between rotational outcomes and ocular biometric parameters are analyzed using linear mixed-effects models to inform individualized IOL selection and perioperative management.
- Conditions
- Cataract
- Being tested
- TECNIS Toric II (ZCU), AcrySof IQ Toric, AT TORBI 709M
- Keywords
- toric intraocular lens, rotational stability, cataract, astigmatism
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TECNIS Toric II (ZCU)Device
Using TECNIS Toric II (ZCU) intraocular lens during standard phacoemulsification cataract surgery.
AcrySof IQ ToricDevice
Using AcrySof IQ Toric intraocular lens during standard phacoemulsification cataract surgery.
AT TORBI 709MDevice
Using the AT TORBI 709M intraocular lens during standard phacoemulsification cataract surgery.
| Study group | Role | What they receive |
|---|---|---|
| TECNIS Toric II (ZCU) | Active comparator | Participants randomized to this arm receive implantation of the TECNIS Toric II (ZCU) intraocular lens during standard phacoemulsification cataract surgery. Receives: Device: TECNIS Toric II (ZCU) |
| AcrySof IQ Toric | Active comparator | Participants randomized to this arm receive implantation of the AcrySof IQ Toric intraocular lens during standard phacoemulsification cataract surgery. Receives: Device: AcrySof IQ Toric |
| AT TORBI 709M | Active comparator | Participants randomized to this arm receive implantation of the AT TORBI 709M intraocular lens during standard phacoemulsification cataract surgery. Receives: Device: AT TORBI 709M |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute rotational misalignment of toric intraocular lens (IOL) measured in degrees
Absolute rotation of the implanted toric intraocular lens (IOL) relative to the intended axis, measured in degrees. Rotation will be quantified by registering postoperative retroillumination images to the end-of-surgery baseline frame using iris or scleral landmarks. The absolute rotation angle will be calculated for each follow-up visit.
Measured: Postoperative day 1, day 3, week 1, week 2, month 1, and month 3.
Secondary outcomes (2)
Uncorrected and corrected distance visual acuity (UDVA and CDVA)
Uncorrected distance visual acuity (UDVA) and corrected distance visual acuity (CDVA) measured using a standardized logarithm of the minimum angle of resolution (logMAR) visual acuity chart during follow-up.
Measured: postoperatively on 1 day, 3 days, 1 week, 2 weeks, 1 month and 3 months
Postoperative residual refractive astigmatism measured in diopters
Residual refractive astigmatism measured by manifest refraction during follow-up visits and reported in diopters (D).
Measured: Postoperative day 1, day 3, week 1, week 2, month 1, and month 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start1 Jan 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2030 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jin Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jin Yang, Eye & ENT Hospital of Fudan University
- Investigators
- Jin Yang, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07453992
- Sponsor's protocol ID
- Totic-2026-001
- Other IDs
- 82171039
- Acronym
- 3 TORIC ROTATE
- Status last verified
- Jan 2026
- First submitted
- 18 Jan 2026
- Last updated
- 6 Mar 2026
- 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 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Rotational Dynamics of Different Toric Intraocular Lens Designs
- ClinicalTrials.gov ID
- NCT07453992
- Acronym / sponsor ID
- 3 TORIC ROTATE / Totic-2026-001
- Conditions
- Cataract
- Keywords
- toric intraocular lens, rotational stability, cataract, astigmatism
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Jin YangUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 6 Mar 2026 (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 prospective comparative cohort study evaluates and compares postoperative rotational stability and time-course dynamics of three commercially available toric intraocular lenses (TECNIS Toric II [ZCU], AcrySof IQ Toric, and AT TORBI 709M) after phacoemulsification cataract surgery. Rotation is quantified by registering postoperative retroillumination photographs to the end-of-surgery baseline using iris/scleral landmarks, with follow-up at postoperative day 1, day 3, week 1, week 2, month 1, and month 3. Associations between rotational outcomes and ocular biometric parameters are analyzed using linear mixed-effects models to inform individualized IOL selection and perioperative management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TECNIS Toric II (ZCU) | Active comparator | Device: TECNIS Toric II (ZCU)Participants randomized to this arm receive implantation of the TECNIS Toric II (ZCU) intraocular lens during standard phacoemulsification cataract surgery. |
| AcrySof IQ Toric | Active comparator | Device: AcrySof IQ ToricParticipants randomized to this arm receive implantation of the AcrySof IQ Toric intraocular lens during standard phacoemulsification cataract surgery. |
| AT TORBI 709M | Active comparator | Device: AT TORBI 709MParticipants randomized to this arm receive implantation of the AT TORBI 709M intraocular lens during standard phacoemulsification cataract surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged 18 years or older with age-related cataract scheduled for phacoemulsification cataract surgery.
- Presence of regular corneal astigmatism requiring toric intraocular lens implantation.
- Eligible for implantation of one of the three study toric intraocular lenses based on preoperative evaluation.
- Ability to understand the study procedures and provide written informed consent.
Key exclusion criteria (8 listed)
- History of prior ocular surgery in the study eye.
- History of ocular trauma in the study eye.
- Irregular corneal astigmatism or corneal pathology affecting reliable biometric measurement.
- Intraoperative complications, including anterior capsular tear or posterior capsular rupture.
- Inadequate pupillary dilation during surgery or postoperative examinations.
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 |
|---|---|---|
| TECNIS Toric II (ZCU)Using TECNIS Toric II (ZCU) intraocular lens during standard phacoemulsification cataract surgery. | Device | TECNIS Toric II (ZCU) |
| AcrySof IQ ToricUsing AcrySof IQ Toric intraocular lens during standard phacoemulsification cataract surgery. | Device | AcrySof IQ Toric |
| AT TORBI 709MUsing the AT TORBI 709M intraocular lens during standard phacoemulsification cataract surgery. | Device | AT TORBI 709M |
Primary outcome
Absolute rotational misalignment of toric intraocular lens (IOL) measured in degrees
Time frame: Postoperative day 1, day 3, week 1, week 2, month 1, and month 3.
Absolute rotation of the implanted toric intraocular lens (IOL) relative to the intended axis, measured in degrees. Rotation will be quantified by registering postoperative retroillumination images to the end-of-surgery baseline frame using iris or scleral landmarks. The absolute rotation angle will be calculated for each follow-up visit.
2 secondary outcomes
Uncorrected and corrected distance visual acuity (UDVA and CDVA)
Time frame: postoperatively on 1 day, 3 days, 1 week, 2 weeks, 1 month and 3 months
Postoperative residual refractive astigmatism measured in diopters
Time frame: Postoperative day 1, day 3, week 1, week 2, month 1, and month 3.
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 Mar 2026.
- 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.
Jin Yang principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TECNIS Toric II (ZCU), AcrySof IQ Toric and AT TORBI 709M in people with Cataract, run by Jin Yang at 1 site in China.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 6 Mar 2026. 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 China. 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?
Contact Xuanqiao Lin (+8615088920668, 1532483480@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute rotational misalignment of toric intraocular lens (IOL) measured in degrees (time frame: Postoperative day 1, day 3, week 1, week 2, month 1, and month 3.). 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 Mar 2026.