CataractNCT06092164
Visual Outcomes of Functional Intraocular Lenses in Cataracts
An observational study of Cataract and Visual Quality, run by Eye & ENT Hospital of Fudan University.
Trial summary
This is a prospective, multi-center, randomized comparative study. The purpose of the study is to evaluate and compare the objective and subjective visual outcomes of different types of functional intraocular lenses (IOLs) in patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Visual Quality
- How many people
- 20,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 30 Dec 2031
- Phase
- Observational
- 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
Study population: Catarct
Who may be able to join
- cataract
- age > 18 years
Who cannot join
- 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Visual Outcomes 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 objective and subjective visual outcomes of different types of functional intraocular lenses (IOLs) in patients.
Read the detailed description
Analyzing the subjective and objective visual outcomes and related factors following the implantation of various types of intraocular lenses（bifocal, trifocal, extended depth of focus (EDOF), and astigmatism-correcting intraocular lenses), exploring the advantages, disadvantages, and suitable patient populations for different types of intraocular lenses, analyzing the factors affecting postoperative visual quality, and providing guidance to better assist patients with diverse needs in clinical settings, aiming to offer multidimensional postoperative visual quality."
- Conditions
- Cataract, Visual Quality
- Medical subject headings
- Cataract
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 (8)
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
The modulation transfer function (MTF) curve
Measured: three months
contrast sensitivity
Contrast sensitivity were obtained from the Functional Vision Analyzer
Measured: three months
visual functions
Visual functions were obtained from the OCULUS Binoptometer 4P
Measured: three months
IOL condition
IOL condition were obtained from the wavefront mode of the OPD-Scan III aberrometer.
Measured: three months
subjective satisfaction
Satisfaction Questionnaire
Measured: three years
photic phenomena
Questionnaire of photic phenomena
Measured: three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start1 Dec 2023 (estimated)
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Dec 2031 (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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Yang, Eye & ENT Hospital of Fudan University
- Investigators
- Jin Yang, Study director, Department of Ophthalmology, Eye and Ear, Nose, and Throat Hospital, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092164
- Sponsor's protocol ID
- IOL Outcomes in cataracts
- Status last verified
- Oct 2023
- First submitted
- 15 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcomes of Different Types of Functional Intraocular Lenses in Cataract Patients
- ClinicalTrials.gov ID
- NCT06092164
- Acronym / sponsor ID
- IOL Outcomes in cataracts
- Conditions
- Cataract, Visual Quality
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Dec 2031 (estimated)
- First posted
- 23 Oct 2023 (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 objective and subjective visual outcomes of different types of functional intraocular lenses (IOLs) in patients.
Detailed description
Analyzing the subjective and objective visual outcomes and related factors following the implantation of various types of intraocular lenses（bifocal, trifocal, extended depth of focus (EDOF), and astigmatism-correcting intraocular lenses), exploring the advantages, disadvantages, and suitable patient populations for different types of intraocular lenses, analyzing the factors affecting postoperative visual quality, and providing guidance to better assist patients with diverse needs in clinical settings, aiming to offer multidimensional postoperative visual quality."
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Catarct
Key inclusion criteria (2 listed)
- cataract
- age > 18 years
Key exclusion criteria (3 listed)
- 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.
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
8 secondary outcomes
HOAs
Time frame: three months
Strehl Ratio
Time frame: three months
objective visual quality
Time frame: three months
contrast sensitivity
Time frame: three months
visual functions
Time frame: three months
IOL condition
Time frame: three months
subjective satisfaction
Time frame: three years
photic phenomena
Time frame: three years
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 23 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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 study director
Department of Ophthalmology, Eye and Ear, Nose, and Throat Hospital, Fudan University
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Visual Quality, run by Eye & ENT Hospital of Fudan University.
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 2 inclusion and 3 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: opening soon, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Jin Yang (+8613671632525, jin_er76@hotmail.com), or a site near the patient. 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 23 Oct 2023.