CataractNCT06719882
Vivity Study in Taiwan
An observational study of Cataract, run by Taipei Nobel Eye Clinic at 1 site in Taiwan.
Trial summary
The aim of study is to evaluate the quality of vision after bilateral Vivity or Vivity toric EDOF IOLs implantation in Taiwan. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Dec 2022to 5 Nov 2024
- How long will I take part?
- 3 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who intended for sequential bilateral cataract surgery and implanted with Vivity/Vivity IOL would be asked to include in this study.
Who may be able to join
- Patients with age-related cataract requiring surgery treatment
- Patient who received bilateral, uneventful implantation of Vivity IOLs
- Patient's IOL power is between 10-30D, and T2-T6 for toric correction
- Cataract grade 0~3 based on the Wisconsin cataract grading system
- Exclusion criteria:
- Cataract grade 4~5 based on the Wisconsin cataract grading system
Show all 17Show fewer
- Patient's IOL power is outside of 10-30D or T2-T6 for toric correction
- Patient with the following ocular comorbidities:
- Corneal opacities or irregularities;
- Severe dry eye;
- Amblyopia;
- Glaucoma;
- Non-dilating pupil;
- History of intraocular surgery, laser therapy, or retinopathy;
- Optic nerve or macular diseases;
- Uncontrolled diabetic mellitus or systemic immune disease;
- Refusal or unable to maintain follow-up
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study of Vivity & Vivity Toric IOL in Taiwan: Results and Analysis
The aim of study is to evaluate the quality of vision after bilateral Vivity or Vivity toric EDOF IOLs implantation in Taiwan.
Read the detailed description
This study was a prospective, single arm study. The inclusion criteria for this study were the presence of cataracts in both eyes and corrected distance visual acuity (CDVA) of both eyes under 20/40, who received bilateral Vivity IOL implantation after cataract surgery, targeting emmetropia or mini-monovision of both eyes. Phacoemulsification cataract surgery was performed on all patients. The exclusion criteria were complicated cataract; corneal opacities or irregularities; severe dry eye (Schirmer's test I ≤ 5 mm); amblyopia; anisometropia; surgical complications such as posterior capsular bag rupture, vitreous loss, or IOL tilt/decentration; coexisting ocular pathologies such as glaucoma, nondilating pupil, history of intraocular surgery, refractive surgery, or retinopathy; optic nerve or macular diseases; and refusal or inability to maintain follow-up. When corneal astigmatism was more than 0.75 diopters (D), a toric IOL was implanted.
- Conditions
- Cataract
- Keywords
- Intraocular lens, Extended depth of focus
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Vivity/Vivity toric | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity (LogMAR)
Uncorrected binocular far, intermediate and near visual acuity. Corrected binocular far, intermediate and near visual acuity.
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start15 Dec 2022
- Primary completion7 Oct 2024
- Study completion5 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Taipei Nobel Eye Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao-Kai Chang, Taipei Nobel Eye Clinic
- Investigators
- ChaoKai Chang, Ph.D., Study director, Taiwan Nobel Eye Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719882
- Sponsor's protocol ID
- 005
- Status last verified
- Oct 2026
- First submitted
- 10 Nov 2024
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kandavel R, Colvard M, Dredge J, Bayle M, Alam T, Snyder J, Hall B. Comparative Study Between Non-Diffractive Extended Depth of Focus and Monofocal Intraocular Lenses. Clin Ophthalmol. 2023 Apr 14;17:1161-1168. doi: 10.2147/OPTH.S402069. eCollection 2023.
PubMed 37082300Hovanesian JA, Jones M, Allen Q. The Vivity Extended Range of Vision IOL vs the PanOptix Trifocal, ReStor 2.5 Active Focus and ReStor 3.0 Multifocal Lenses: A Comparison of Patient Satisfaction, Visual Disturbances, and Spectacle Independence. Clin Ophthalmol. 2022 Jan 18;16:145-152. doi: 10.2147/OPTH.S347382. eCollection 2022.
PubMed 35082481
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Vivity & Vivity Toric IOL in Taiwan: Results and Analysis
- ClinicalTrials.gov ID
- NCT06719882
- Acronym / sponsor ID
- 005
- Conditions
- Cataract
- Keywords
- Intraocular lens, Extended depth of focus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Taipei Nobel Eye ClinicUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 7 Oct 2024 (actual)
- Study completion
- 5 Nov 2024 (actual)
- First posted
- 6 Dec 2024 (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.
The aim of study is to evaluate the quality of vision after bilateral Vivity or Vivity toric EDOF IOLs implantation in Taiwan.
Detailed description
This study was a prospective, single arm study. The inclusion criteria for this study were the presence of cataracts in both eyes and corrected distance visual acuity (CDVA) of both eyes under 20/40, who received bilateral Vivity IOL implantation after cataract surgery, targeting emmetropia or mini-monovision of both eyes. Phacoemulsification cataract surgery was performed on all patients. The exclusion criteria were complicated cataract; corneal opacities or irregularities; severe dry eye (Schirmer's test I ≤ 5 mm); amblyopia; anisometropia; surgical complications such as posterior capsular bag rupture, vitreous loss, or IOL tilt/decentration; coexisting ocular pathologies such as glaucoma, nondilating pupil, history of intraocular surgery, refractive surgery, or retinopathy; optic nerve or macular diseases; and refusal or inability to maintain follow-up. When corneal astigmatism was more than 0.75 diopters (D), a toric IOL was implanted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vivity/Vivity toric | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who intended for sequential bilateral cataract surgery and implanted with Vivity/Vivity IOL would be asked to include in this study.
Key inclusion criteria (17 listed)
- Patients with age-related cataract requiring surgery treatment
- Patient who received bilateral, uneventful implantation of Vivity IOLs
- Patient's IOL power is between 10-30D, and T2-T6 for toric correction
- Cataract grade 0~3 based on the Wisconsin cataract grading system
- Cataract grade 4~5 based on the Wisconsin cataract grading system
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Visual acuity (LogMAR)
Time frame: From enrollment to the end of treatment at 3 months
Uncorrected binocular far, intermediate and near visual acuity. Corrected binocular far, intermediate and near visual acuity.
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 6 Oct 2026.
- Results publication: PubMed 37082300Kandavel R, Colvard M, Dredge J, Bayle M, Alam T, Snyder J, Hall B. Comparative Study Between Non-Diffractive Extended Depth of Focus and Monofocal Intraocular Lenses. Clin Ophthalmol. 2023 Apr 14;17:1161-1168. doi: 10.2147/OPTH.S402069. eCollection 2023.
- Results publication: PubMed 35082481Hovanesian JA, Jones M, Allen Q. The Vivity Extended Range of Vision IOL vs the PanOptix Trifocal, ReStor 2.5 Active Focus and ReStor 3.0 Multifocal Lenses: A Comparison of Patient Satisfaction, Visual Disturbances, and Spectacle Independence. Clin Ophthalmol. 2022 Jan 18;16:145-152. doi: 10.2147/OPTH.S347382. eCollection 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.
ChaoKai Chang, Ph.D. study director
Taiwan Nobel Eye Clinic
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, run by Taipei Nobel Eye Clinic at 1 site in Taiwan.
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 17 inclusion and 0 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 6 Oct 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 Taiwan. 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?
Visual acuity (LogMAR) (time frame: From enrollment to the end of treatment at 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06719882, which also lists 2 linked publications.
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 Oct 2026.