CataractNCT06658119
Clinical Evaluation of Extended Depth-of-focus Intraocular Lens in Refractive Cataract Surgery: a Randomized Controlled Trial
A study testing cataract surgery in people with Cataract, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to compare the clinical outcomes of two extended depth-of-focus intraocular lens after cataract surgery. The randomized controlled trail will enroll 90 participants. The participants will be randomly assigned to implant Tecnis Synergy ZFR00 or Tecnis Symfony ZXR00 intraocular lens. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Cataract
- What is being tested?
- cataract surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 15 Dec 2024to 1 Mar 2026
- Phase
- Interventional
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age-related cataract patients aged between 40 to 80
- patients with preoperative astigmatism less than 0.75 D, and kappa value less than 0.7 mm
- patients who plan to receive femtosecond laser-assisted cataract surgery
Who cannot join
- patients with ocular surface abnormalities such as irregular corneal astigmatism, corneal scarring, keratoconus, and pterygium)
- patients with history of ocular trauma or surgery
- patients with coexisting ocular disorders such as glaucoma, retinal vascular occlusive disease, retinal detachment, diabetic retinopathy, and any optic nerve-related pathologies
- patients with concurrent severe systemic diseases
- patients who lack of cooperation
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Eye Center of the Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310058
Yueyang Zhong, 18868125901, annie.zhongyy@gmail.com
About this study
Official title: Clinical Evaluation of Extended Depth-of-focus Intraocular Lens in Refractive Cataract Surgery
The goal of this clinical trial is to compare the clinical outcomes of two extended depth-of-focus intraocular lens after cataract surgery. The randomized controlled trail will enroll 90 participants. The participants will be randomly assigned to implant Tecnis Synergy ZFR00 or Tecnis Symfony ZXR00 intraocular lens. Follow-up visit will be performed till 3 months postoperatively to compare the visual acuity, subjective manifest refraction, and visual quality between groups.
- Conditions
- Cataract
- Being tested
- cataract surgery
- Keywords
- cataract surgery, 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.
cataract surgeryProcedure or surgery
Also called intraocular lens implantation
The participants will receive femtosecond laser-assisted cataract surgery and implant an extended depth-of-focus intraocular lens (Tecnis Synergy ZFR00).
cataract surgeryProcedure or surgery
Also called intraocular lens implantation
The participants will receive femtosecond laser-assisted cataract surgery and implant an extended depth-of-focus intraocular lens (Tecnis Symfony ZXR00).
| Study group | Role | What they receive |
|---|---|---|
| Tecnis Synergy ZFR00 IOL | Experimental | Tecnis Synergy ZFR00 IOL will be implanted in the patient's eye during cataract surgery. Receives: Procedure: cataract surgery |
| Tecnis Symfony ZXR00 IOL | Placebo comparator | Tecnis Symfony ZXR00 IOL will be implanted in the patient's eye during cataract surgery. Receives: Procedure: cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Visual acuity will be assessed using the Standard Logarithmic Visual Acuity Chart. The results will be recorded in decimal and converted to logMAR and Snellen equivalent.
Measured: 1 day, 1 week, 1 month, 3 months postoperatively
Secondary outcomes (3)
Visual quality
OPD-scan measurement. Higher-order aberration, tilt and decentration will be recorded.
Measured: 3 months postoperatively
defocus curve
Best distance visual acuity varied from - 5.00 to + 2.00 D in steps of 0.50 D under photopic conditions was recorded.
Measured: 3 months postoperatively
contrast sensitivity
Contrast sensitivity will be converted to logarithmic scale before analysis and referred to as log-contrast sensitivity.
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start15 Dec 2024
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Mar 2026 (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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- 90 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658119
- Sponsor's protocol ID
- 20241068
- Status last verified
- Oct 2024
- First submitted
- 23 Oct 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Extended Depth-of-focus Intraocular Lens in Refractive Cataract Surgery
- ClinicalTrials.gov ID
- NCT06658119
- Acronym / sponsor ID
- 20241068
- Conditions
- Cataract
- Keywords
- cataract surgery, intraocular lens, extended depth-of-focus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 15 Dec 2024 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 26 Oct 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 goal of this clinical trial is to compare the clinical outcomes of two extended depth-of-focus intraocular lens after cataract surgery. The randomized controlled trail will enroll 90 participants. The participants will be randomly assigned to implant Tecnis Synergy ZFR00 or Tecnis Symfony ZXR00 intraocular lens. Follow-up visit will be performed till 3 months postoperatively to compare the visual acuity, subjective manifest refraction, and visual quality between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tecnis Synergy ZFR00 IOL | Experimental | Procedure: cataract surgeryTecnis Synergy ZFR00 IOL will be implanted in the patient's eye during cataract surgery. |
| Tecnis Symfony ZXR00 IOL | Placebo comparator | Procedure: cataract surgeryTecnis Symfony ZXR00 IOL will be implanted in the patient's eye during cataract surgery. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age-related cataract patients aged between 40 to 80
- patients with preoperative astigmatism less than 0.75 D, and kappa value less than 0.7 mm
- patients who plan to receive femtosecond laser-assisted cataract surgery
Key exclusion criteria (5 listed)
- patients with ocular surface abnormalities such as irregular corneal astigmatism, corneal scarring, keratoconus, and pterygium)
- patients with history of ocular trauma or surgery
- patients with coexisting ocular disorders such as glaucoma, retinal vascular occlusive disease, retinal detachment, diabetic retinopathy, and any optic nerve-related pathologies
- patients with concurrent severe systemic diseases
- patients who lack of cooperation
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 |
|---|---|---|
| cataract surgeryAlso: intraocular lens implantationThe participants will receive femtosecond laser-assisted cataract surgery and implant an extended depth-of-focus intraocular lens (Tecnis Synergy ZFR00). | Procedure or surgery | Tecnis Synergy ZFR00 IOL |
| cataract surgeryAlso: intraocular lens implantationThe participants will receive femtosecond laser-assisted cataract surgery and implant an extended depth-of-focus intraocular lens (Tecnis Symfony ZXR00). | Procedure or surgery | Tecnis Symfony ZXR00 IOL |
Primary outcome
Visual acuity
Time frame: 1 day, 1 week, 1 month, 3 months postoperatively
Visual acuity will be assessed using the Standard Logarithmic Visual Acuity Chart. The results will be recorded in decimal and converted to logMAR and Snellen equivalent.
3 secondary outcomes
Visual quality
Time frame: 3 months postoperatively
defocus curve
Time frame: 3 months postoperatively
contrast sensitivity
Time frame: 3 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cataract surgery in people with Cataract, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 3 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: status not confirmed, as of the sponsor's last update on 5 Mar 2025. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yueyang Zhong, MD. (+8618868125901, yyzbzhong@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 1 day, 1 week, 1 month, 3 months postoperatively). 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 5 Mar 2025.