High MyopiaNCT05581888
Visual Performance of Functional Intraocular Lenses in Cataracts
A study testing trifocal intraocular lens in people with High Myopia and Cataract, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
This is a prospective, multi-center, randomized comparative study. The purpose of the study is to evaluate and compare the postoperative visual outcomes and quality of vision of two diffractive trifocal intraocular lenses (IOLs) in patients with high myopic cataracts. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- High Myopia, Cataract
- What is being tested?
- trifocal intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2020to 31 Mar 2023
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- required binocular cataract extraction
- age > 21 years
- length of optic axis > 26 mm
Who cannot join
- irregular corneal astigmatism > 0.3 um;
- amblyopia; previous ocular surgery;
- ocular pathologies such as diabetic retinopathy, macular degeneration, glaucoma with field defects;
- requirements for further ocular surgery (other than Nd:YAG capsulotomy) or retinal laser treatments during the study
Trial locations and contacts
1 site in 1 country.
China1 site
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
About this study
Official title: Visual Performance of Different Types of Functional Intraocular Lenses in Cataract Patients
This is a prospective, multi-center, randomized comparative study. The purpose of the study is to evaluate and compare the postoperative visual outcomes and quality of vision of two diffractive trifocal intraocular lenses (IOLs) in patients with high myopic cataracts.
Read the detailed description
Binocular implantation of two types of trifocal IOLs was performed in patients with high myopic cataracts. Postoperative uncorrected distance (UNVA), intermediate (UIVA), near (UNVA), and best-corrected distance visual acuity (BCVA) were measured. Defocus curve, high-order aberrations, modulation transfer function curve, Strehl ratio and reading ability were compared between the two groups. The functional vision and incidence of photic phenomena were surveyed using questionnaires.
- Conditions
- High Myopia, Cataract
- Being tested
- trifocal intraocular lens
- Keywords
- Visual performance, Trifocal IOL, High myopic cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trifocal intraocular lensDevice
Binocular implantation of two different trifocal intraocular lens in high myopic cataracts
| Study group | Role | What they receive |
|---|---|---|
| 839MP group | Other | Patients in this group were binocularly implanted with the AT LISA tri 839MP trifocal intraocular lens. Receives: Device: trifocal intraocular lens |
| TFNT00 group | Other | Patients in this group were binocularly implanted with the AcrySof IQ PanOptix TFNT00 trifocal intraocular lens. Receives: Device: trifocal intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
uncorrected distance visual acuity (UDVA)
uncorrected visual acuity at 5 m
Measured: one year
best corrected distance visual acuity (BCVA)
corrected visual acuity at 5 m
Measured: one year
uncorrected near visual acuity (UNVA)
uncorrected visual acuity at 40 cm
Measured: one year
uncorrected intermediate visual acuity (UIVA)
uncorrected visual acuity at 60 cm
Measured: one year
Secondary outcomes (3)
HOAs
high order aberrations such as coma
Measured: three months
Strehl Ratio
The derivative of point spread function (PSF)
Measured: three months
objective visual quality
MTF curves
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start1 Apr 2020
- Primary completion30 Jun 2021
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High MyopiaStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan UniversityThe 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
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jin Yang, Study director, Department of Ophthalmology, Eye and Ear, Nose, and Throat Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05581888
- Sponsor's protocol ID
- Functional IOLs in cataracts
- Status last verified
- Nov 2022
- First submitted
- 19 Sep 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Performance of Different Types of Functional Intraocular Lenses in Cataract Patients
- ClinicalTrials.gov ID
- NCT05581888
- Acronym / sponsor ID
- Functional IOLs in cataracts
- Conditions
- High Myopia, Cataract
- Keywords
- Visual performance, Trifocal IOL, High myopic cataract
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 17 Oct 2022 (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 is a prospective, multi-center, randomized comparative study. The purpose of the study is to evaluate and compare the postoperative visual outcomes and quality of vision of two diffractive trifocal intraocular lenses (IOLs) in patients with high myopic cataracts.
Detailed description
Binocular implantation of two types of trifocal IOLs was performed in patients with high myopic cataracts. Postoperative uncorrected distance (UNVA), intermediate (UIVA), near (UNVA), and best-corrected distance visual acuity (BCVA) were measured. Defocus curve, high-order aberrations, modulation transfer function curve, Strehl ratio and reading ability were compared between the two groups. The functional vision and incidence of photic phenomena were surveyed using questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 839MP group | Other | Device: trifocal intraocular lensPatients in this group were binocularly implanted with the AT LISA tri 839MP trifocal intraocular lens. |
| TFNT00 group | Other | Device: trifocal intraocular lensPatients in this group were binocularly implanted with the AcrySof IQ PanOptix TFNT00 trifocal intraocular lens. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- required binocular cataract extraction
- age > 21 years
- length of optic axis > 26 mm
Key exclusion criteria (4 listed)
- irregular corneal astigmatism > 0.3 um;
- amblyopia; previous ocular surgery;
- ocular pathologies such as diabetic retinopathy, macular degeneration, glaucoma with field defects;
- requirements for further ocular surgery (other than Nd:YAG capsulotomy) or retinal laser treatments during the study
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 |
|---|---|---|
| trifocal intraocular lensBinocular implantation of two different trifocal intraocular lens in high myopic cataracts | Device | 839MP group, TFNT00 group |
Primary outcome
uncorrected distance visual acuity (UDVA)
Time frame: one year
uncorrected visual acuity at 5 m
best corrected distance visual acuity (BCVA)
Time frame: one year
corrected visual acuity at 5 m
uncorrected near visual acuity (UNVA)
Time frame: one year
uncorrected visual acuity at 40 cm
uncorrected intermediate visual acuity (UIVA)
Time frame: one year
uncorrected visual acuity at 60 cm
3 secondary outcomes
HOAs
Time frame: three months
Strehl Ratio
Time frame: three months
objective visual quality
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
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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.
Jin Yang study director
Department of Ophthalmology, Eye and Ear, Nose, and Throat Hospital, 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 trifocal intraocular lens in people with High Myopia and Cataract, run by Eye & ENT Hospital of Fudan 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 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: status not confirmed, as of the sponsor's last update on 3 Nov 2022. 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?
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?
uncorrected distance visual acuity (UDVA) (time frame: one year). The study lists 4 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 3 Nov 2022.