CataractNCT05042856
To Evaluate IOL Position, Clinical Outcome of PanOptix in High Myopic Cataract Patients
A study testing PanOptix IOL implantation in people with Cataract and High Myopia, run by Wenzhou Medical University at 1 site in China.
Trial summary
To evaluate IOL position, clinical outcome of PanOptix in high myopic cataract patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, High Myopia
- What is being tested?
- PanOptix IOL implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2021to 30 Sep 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years old
- 26 ≤Axial length<30mm, IOL power ≥6D (PanOptix IOL power is available +6D-+30D )
- Eyes with corneal astigmatism less than 1.0D (IOLMaster 700, Carl Zeiss Meditec AG)
- Eyes with pupil diameter between 3 and 5.5 mm (iTrace, Tracey Technology, Houston, Texas, USA)
- Eyes with angle kappa and angle Alpha ≤0.50 mm (iTrace);
- Eyes with corneal spherical aberration ≤ 0.50 (Pentacam).
Who cannot join
- Irregular corneal astigmatism
- Serious intraoperative complications, glaucoma, pseudoexfoliation syndrome, uveitis, macular degeneration or other retinal impairment
- Moderate-severe dry eye, corneal scarring, amblyopia
- Patients who can't cooperate with post-op 3 months follow-up.
Trial locations and contacts
1 site in 1 country.
China1 site
Ophthalmology and Optometry Hospital
Wenzhou, Zhejiang, 325027
zhao yun-e, +86 13819707056
About this study
Official title: A Prospective, Single Center Study to Evaluate IOL Position, Clinical Outcome of PanOptix in High Myopic Cataract Patients
To evaluate IOL position, clinical outcome of PanOptix in high myopic cataract patients
Read the detailed description
A prospective, single center study to evaluate IOL position, clinical outcome of PanOptix in high myopic cataract patients.
The objective of this study to investigate the refractive and visual performance of PanOptix and explore their correlation with ELP change, capsular bending formation, IOL tilt/decentration in high myopic cataract patients.
PanOptix IOL provides good refractive outcomes and visual quality because of few ELP change, fast capsular bending formation and few tilt and decentration in high myopic cataract patients.
- Conditions
- Cataract, High Myopia
- Being tested
- PanOptix IOL implantation
- Keywords
- PanOptix IOL, high myopic cataract patients
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PanOptix IOL implantationProcedure or surgery
All the patients will be bilaterally implanted with PanOptix IOL，one eye will be randomized selected for monocular analysis of each patient.
| Study group | Role | What they receive |
|---|---|---|
| PanOptix | Experimental | All the patients will be bilaterally implanted with PanOptix IOL，one eye will be randomized selected for monocular analysis of each patient. Receives: Procedure: PanOptix IOL implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effective Lens Position（ELP）
Mean change of ELP for 3 months
Measured: 3 months
Secondary outcomes (13)
capsule bending index（CBI）
Post-op 1 day，1week，1month，and 3 months monocular CBI(Swept source OCT,Casia SS-1000; Tomey)
Measured: 3months
lOL tilt
Post-op 1 day ,1 week,1 month and 3 months lOL tilt(Swept source OCT,Casia SS-1000; Tomey)
Measured: 3 months
lOL decentration
Post-op 1 day ,1 week,1 month and 3 months lOL decentration(Swept source OCT,Casia SS-1000; Tomey)
Measured: 3 months
Monocular uncorrected distance visual acuity（UDVA）
Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular UDVA(Chinese standard logarithmic charts)
Measured: 3 months
Monocular best corrected distance visual acuity（BCDVA）(5m)
Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular BCDVA(5m)(Chinese standard logarithmic charts)
Measured: 3 months
Monocular uncorrected intermediate visual acuity（UIVA）
Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular UIVA(Chinese standard logarithmic charts)
Measured: 3 months
Monocular distance corrected intermediate visual acuity(DCIVA)(60cm)
Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular DCIVA(60cm)(Chinese standard logarithmic charts)
Measured: 3 months
Monocular uncorrected near visual acuity（UNVA）
Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular UNVA(Chinese standard logarithmic charts)
Measured: 3 months
Monocular distance corrected near visual acuity(DCNVA)(40cm)
Pre-op and post-op 1 day,1 week,1 month and 3 months Monocular DCNVA(40cm)(Chinese standard logarithmic charts)
Measured: 3 months
manifest refraction
Pre-op and post-op 1 day,1 week,1 month and 3 months manifest refraction
Measured: 3 months
Monocular defocus curve
Post-op 1month,3 months monocular defocus curve
Measured: 3 months
modulation transfer function（MTF）
Post-op 1 day,1 week,1 month and 3 months MTF(OPD-Scan III Analyzer,NIDEK CO.,LTD.,Tokyo,Japan)
Measured: 3 months
high-order aberrations（HOA）
Post-op 1 day,1 week,1 month and 3 months HOA(OPD-Scan III Analyzer,NIDEK CO.,LTD.,Tokyo,Japan)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start1 Oct 2021 (estimated)
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yune Zhao, Wenzhou Medical University
- Investigators
- yune zhao, MD, Study chair, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042856
- Sponsor's protocol ID
- ZYY-PanOptix IOL
- Status last verified
- Sep 2021
- First submitted
- 22 Aug 2021
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Center Study to Evaluate IOL Position, Clinical Outcome of PanOptix in High Myopic Cataract Patients
- ClinicalTrials.gov ID
- NCT05042856
- Acronym / sponsor ID
- ZYY-PanOptix IOL
- Conditions
- Cataract, High Myopia
- Keywords
- PanOptix IOL, high myopic cataract patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (estimated)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 13 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.
To evaluate IOL position, clinical outcome of PanOptix in high myopic cataract patients
Detailed description
A prospective, single center study to evaluate IOL position, clinical outcome of PanOptix in high myopic cataract patients.
The objective of this study to investigate the refractive and visual performance of PanOptix and explore their correlation with ELP change, capsular bending formation, IOL tilt/decentration in high myopic cataract patients.
PanOptix IOL provides good refractive outcomes and visual quality because of few ELP change, fast capsular bending formation and few tilt and decentration in high myopic cataract patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PanOptix | Experimental | Procedure: PanOptix IOL implantationAll the patients will be bilaterally implanted with PanOptix IOL，one eye will be randomized selected for monocular analysis of each patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients over 18 years old
- 26 ≤Axial length<30mm, IOL power ≥6D (PanOptix IOL power is available +6D-+30D )
- Eyes with corneal astigmatism less than 1.0D (IOLMaster 700, Carl Zeiss Meditec AG)
- Eyes with pupil diameter between 3 and 5.5 mm (iTrace, Tracey Technology, Houston, Texas, USA)
- Eyes with angle kappa and angle Alpha ≤0.50 mm (iTrace);
Key exclusion criteria (4 listed)
- Irregular corneal astigmatism
- Serious intraoperative complications, glaucoma, pseudoexfoliation syndrome, uveitis, macular degeneration or other retinal impairment
- Moderate-severe dry eye, corneal scarring, amblyopia
- Patients who can't cooperate with post-op 3 months follow-up.
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 |
|---|---|---|
| PanOptix IOL implantationAll the patients will be bilaterally implanted with PanOptix IOL，one eye will be randomized selected for monocular analysis of each patient. | Procedure or surgery | PanOptix |
Primary outcome
Effective Lens Position（ELP）
Time frame: 3 months
Mean change of ELP for 3 months
13 secondary outcomes
capsule bending index（CBI）
Time frame: 3months
lOL tilt
Time frame: 3 months
lOL decentration
Time frame: 3 months
Monocular uncorrected distance visual acuity（UDVA）
Time frame: 3 months
Monocular best corrected distance visual acuity（BCDVA）(5m)
Time frame: 3 months
Monocular uncorrected intermediate visual acuity（UIVA）
Time frame: 3 months
Monocular distance corrected intermediate visual acuity(DCIVA)(60cm)
Time frame: 3 months
Monocular uncorrected near visual acuity（UNVA）
Time frame: 3 months
Monocular distance corrected near visual acuity(DCNVA)(40cm)
Time frame: 3 months
manifest refraction
Time frame: 3 months
Monocular defocus curve
Time frame: 3 months
modulation transfer function（MTF）
Time frame: 3 months
high-order aberrations（HOA）
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
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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.
yune zhao, MD study chair
Wenzhou Medical 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 PanOptix IOL implantation in people with Cataract and High Myopia, run by Wenzhou Medical University 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 6 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: status not confirmed, as of the sponsor's last update on 21 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yinying zhao (+86 13957763247, ginger146@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effective Lens Position（ELP） (time frame: 3 months). 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 21 Sep 2021.