CataractNCT05377515
Evaluation of Visual Outcomes in Patients With Complex Corneas Implanted With the IC-8 IOL
An observational study of Cataract and Presbyopia, run by AcuFocus, Inc. at 1 site in Singapore.
Trial summary
The purpose of this study is to evaluate visual outcomes in patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal. Read more about this study
- Who is it for?
- Ages 22 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cataract, Presbyopia, Irregular; Contour of Cornea
- How many people
- 21 participants
- Where
- 1 siteSingapore
- Study dates
- 10 Feb 2022to 30 Dec 2022
- How long will I take part?
- 1 Day
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients for this study will be recruited from patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal. Anticipated study sample size of up to 40 patients will be evaluated. Patients will be screened for eligibility, and an informed consent will be obtained from those who meet the screening criteria and are interested in participating in the study.
Who may be able to join
- Minimum 22 years of age;
- Able to comprehend and have signed a statement of informed consent;
- Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s);
- Having complex corneas prior to cataract surgery;
- Previous cataract surgery and IC-8 IOL implantation in the eye (implanted for 3 months or longer prior to study participation).
Who cannot join
- Baseline visual acuity worse than 20/25 BCDVA in either eye;
- Presence of ocular abnormalities or conditions other than corneal irregularities that could confound the study outcome(s), such as:
- Strabismus or amblyopia
- Retinal or macular abnormalities
- Recurrent and/or persistent ocular inflammation
- Known pathology that may affect visual acuity to a level worse than 20/25 BCDVA
Show all 11Show fewer
- Previous intraocular surgery, except cataract surgery, pterygium surgery, or corneal procedures (other than corneal-cross linking);
- Previous corneal cross-linking procedure with any corneal haze;
- Conditions requiring planned ocular surgical intervention, except Nd:YAG capsulotomy;
- Severe dry eye or other conditions (such as hormonal fluctuations) that could lead to unstable refraction and/or visual acuity measurements or eye discomfort even with ocular lubricants or dry eye medication;
- Patient is pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Singapore Eye Research Institute / Singapore National Eye Centre
Singapore
About this study
The purpose of this study is to evaluate visual outcomes in patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal.
Read the detailed description
This will be a prospective, non-randomized, single-arm, single-visit, single-center, clinical study in up to 40 patients previously contralaterally implanted with the IC-8 IOL at one clinical site in Singapore.
The purpose of this study is to to evaluate visual outcomes in patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal. The co-primary study endpoints are monocular uncorrected distance, intermediate, near visual acuities.
- Conditions
- Cataract, Presbyopia, Irregular; Contour of Cornea
- Medical subject headings
- Cataract, Presbyopia
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 |
|---|---|---|
| IC-8 IOL Group | Visual outcomes in patients previously contralaterally implanted with the IC-8 IOL will be evaluated. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular UCDVA
0.3 logMAR or better
Measured: 3 Months
Monocular UCIVA
0.3 logMAR or better
Measured: 3 Months
Monocular UCNVA
not worse than 0.3 logMAR
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 posted17 May 2022
- Study start10 Feb 2022
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- AcuFocus, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Magda Michna, Ph.D., Study director, AcuFocus, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377515
- Sponsor's protocol ID
- IC8-303-EXPA
- Status last verified
- May 2023
- First submitted
- 12 May 2022
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Visual Outcomes in Patients With Complex Corneas Implanted With the IC-8 IOL
- ClinicalTrials.gov ID
- NCT05377515
- Acronym / sponsor ID
- IC8-303-EXPA
- Conditions
- Cataract, Presbyopia, Irregular; Contour of Cornea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- AcuFocus, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 17 May 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.
The purpose of this study is to evaluate visual outcomes in patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal.
Detailed description
This will be a prospective, non-randomized, single-arm, single-visit, single-center, clinical study in up to 40 patients previously contralaterally implanted with the IC-8 IOL at one clinical site in Singapore.
The purpose of this study is to to evaluate visual outcomes in patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal. The co-primary study endpoints are monocular uncorrected distance, intermediate, near visual acuities.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IC-8 IOL Group | – | –Visual outcomes in patients previously contralaterally implanted with the IC-8 IOL will be evaluated. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients for this study will be recruited from patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal. Anticipated study sample size of up to 40 patients will be evaluated. Patients will be screened for eligibility, and an informed consent will be obtained from those who meet the screening criteria and are interested in participating in the study.
Key inclusion criteria (5 listed)
- Minimum 22 years of age;
- Able to comprehend and have signed a statement of informed consent;
- Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s);
- Having complex corneas prior to cataract surgery;
- Previous cataract surgery and IC-8 IOL implantation in the eye (implanted for 3 months or longer prior to study participation).
Key exclusion criteria (11 listed)
- Baseline visual acuity worse than 20/25 BCDVA in either eye;
- Presence of ocular abnormalities or conditions other than corneal irregularities that could confound the study outcome(s), such as:
- Previous intraocular surgery, except cataract surgery, pterygium surgery, or corneal procedures (other than corneal-cross linking);
- Previous corneal cross-linking procedure with any corneal haze;
- Conditions requiring planned ocular surgical intervention, except Nd:YAG capsulotomy;
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
Monocular UCDVA
Time frame: 3 Months
0.3 logMAR or better
Monocular UCIVA
Time frame: 3 Months
0.3 logMAR or better
Monocular UCNVA
Time frame: 3 Months
not worse than 0.3 logMAR
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 10 May 2023.
- 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.
Magda Michna, Ph.D. study director
AcuFocus, Inc.
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 and Presbyopia, run by AcuFocus, Inc. at 1 site in Singapore.
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 5 inclusion and 11 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 10 May 2023. 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 Singapore. 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?
Monocular UCDVA (time frame: 3 Months). The study lists 3 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 10 May 2023.