CataractNCT05574270
Clinical Investigation of a Small Aperture Extended Depth of Focus Intraocular Lens in Patients With Complex Corneas
A study testing IC-8 Intraocular Lens (IOL) in people with Cataract and Presbyopia, run by AcuFocus, Inc. at 2 sites in 2 countries.
Trial summary
The objective of this study is to evaluate the clinical outcomes of the IC-8 IOL implanted in patients with complex corneas after crystalline lens 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 Astigmatism
- What is being tested?
- IC-8 Intraocular Lens (IOL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 Jul 2022to 28 Nov 2024
- 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 22 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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);
- Planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber IOL implantation;
- Planned cataract removal or planned clear lens exchange in both eyes
- Potential for postoperative best-corrected distance visual acuity (BCDVA) of 20/32 or better after crystalline lens removal;
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- Having complex corneas with irregular astigmatism
- Having clear central cornea
- Having best-corrected distance visual acuity (BCDVA) or 20/40 or worse in either eye with or without a glare source (patients with bilateral cataract).
Who cannot join
- Requiring an IC-8 IOL outside the available spherical power range;
- Pharmacologically dilated pupil size less than 6 mm in either eye;
- Preoperative corneal astigmatism >1.50 diopters in the eye to be implanted with the IC-8 IOL;
- Active or recurrent anterior segment pathology;
- Presence of ocular abnormalities or conditions (other than corneal irregularities) as specified by the protocol;
- Congenital bilateral cataracts;
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- Previous ocular surgery as specified by the protocol;
- Conditions requiring planned ocular surgical intervention;
- 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;
- Use of systemic or ocular medications as specified by the protocol;
- Concurrent participation or participation in any clinical investigation up to 30 days prior to preoperative visit;
- Patient is pregnant or nursing.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Singapore1 site
Singapore National Eye Centre (SNEC); Singapore Eye Research Institute (SERI)
Singapore
About this study
The objective of this study is to evaluate the clinical outcomes of the IC-8 IOL implanted in patients with complex corneas after crystalline lens removal.
Read the detailed description
This is a prospective, multi-center, open-label, non-randomized, single-arm clinical investigation with planned postoperative follow-up of 4-6 months. The monocular and binocular performance of the subjects will be evaluated.
The objective of this study is to evaluate the clinical outcomes of the IC-8 IOL implanted in patients with complex corneas after crystalline lens removal.
The co-primary effectiveness endpoints are monocular uncorrected distance, intermediate, and near visual acuities at 4-6 Months postoperative. The primary safety endpoint is best-corrected distance visual acuity at 4-6 Months postoperative. The secondary safety endpoint is photopic and mesopic contrast sensitivity at 4-6 Months postoperative.
- Conditions
- Cataract, Presbyopia, Irregular Astigmatism
- Being tested
- IC-8 Intraocular Lens (IOL)
- Medical subject headings
- Cataract, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IC-8 Intraocular Lens (IOL)Device
Also called IC-8 IOL
A small aperture extended depth of focus hydrophobic acrylic intraocular lens.
| Study group | Role | What they receive |
|---|---|---|
| IC-8 IOL Group | Experimental | A monofocal or monofocal toric IOL implanted in the first eye of a subject and the IC-8 IOL implanted in the second eye. Receives: Device: IC-8 Intraocular Lens (IOL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monocular uncorrected distance visual acuity (UCDVA)
Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative
Measured: 4-6 Months
Monocular uncorrected intermediate visual acuity (UCIVA)
Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative
Measured: 4-6 Months
Monocular uncorrected near visual acuity (UCNVA)
Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative
Measured: 4-6 Months
Monocular best-corrected distance visual acuity (BCDVA) in the IC-8 IOL eye
Mean best-corrected distance visual acuity (BCDVA) in the IC-8 IOL eye at 4-6 Months is not statistically worse than 0.2 logMAR
Measured: 4-6 Months
Secondary outcomes (1)
Monocular and Binocular Contrast Sensitivity
Photopic and Mesopic contrast sensitivity (with and without glare) in each eye and both eyes will be analyzed. No success criterion or hypothesis testing.
Measured: 4-6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start12 Jul 2022
- Primary completion28 Nov 2024
- Study completion28 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 45 participants (actual)
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
- NCT05574270
- Sponsor's protocol ID
- IC8-204-EXP2
- Status last verified
- Dec 2024
- First submitted
- 7 Oct 2022
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ang RET. Visual Outcomes Following Cataract Surgery and Implantation of a Small-Aperture Intraocular Lens in Post-Refractive Surgery Patients. Clin Ophthalmol. 2026 Feb 19;20:571174. doi: 10.2147/OPTH.S571174. eCollection 2026.
PubMed 41737854
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of a Small Aperture Extended Depth of Focus Intraocular Lens in Patients With Complex Corneas
- ClinicalTrials.gov ID
- NCT05574270
- Acronym / sponsor ID
- IC8-204-EXP2
- Conditions
- Cataract, Presbyopia, Irregular Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- AcuFocus, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Jul 2022 (actual)
- Primary completion
- 28 Nov 2024 (actual)
- Study completion
- 28 Nov 2024 (actual)
- First posted
- 10 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.
The objective of this study is to evaluate the clinical outcomes of the IC-8 IOL implanted in patients with complex corneas after crystalline lens removal.
Detailed description
This is a prospective, multi-center, open-label, non-randomized, single-arm clinical investigation with planned postoperative follow-up of 4-6 months. The monocular and binocular performance of the subjects will be evaluated.
The objective of this study is to evaluate the clinical outcomes of the IC-8 IOL implanted in patients with complex corneas after crystalline lens removal.
The co-primary effectiveness endpoints are monocular uncorrected distance, intermediate, and near visual acuities at 4-6 Months postoperative. The primary safety endpoint is best-corrected distance visual acuity at 4-6 Months postoperative. The secondary safety endpoint is photopic and mesopic contrast sensitivity at 4-6 Months postoperative.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IC-8 IOL Group | Experimental | Device: IC-8 Intraocular Lens (IOL)A monofocal or monofocal toric IOL implanted in the first eye of a subject and the IC-8 IOL implanted in the second eye. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 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);
- Planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber IOL implantation;
- Planned cataract removal or planned clear lens exchange in both eyes
Key exclusion criteria (12 listed)
- Requiring an IC-8 IOL outside the available spherical power range;
- Pharmacologically dilated pupil size less than 6 mm in either eye;
- Preoperative corneal astigmatism >1.50 diopters in the eye to be implanted with the IC-8 IOL;
- Active or recurrent anterior segment pathology;
- Presence of ocular abnormalities or conditions (other than corneal irregularities) as specified by the protocol;
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 |
|---|---|---|
| IC-8 Intraocular Lens (IOL)Also: IC-8 IOLA small aperture extended depth of focus hydrophobic acrylic intraocular lens. | Device | IC-8 IOL Group |
Primary outcome
Monocular uncorrected distance visual acuity (UCDVA)
Time frame: 4-6 Months
Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative
Monocular uncorrected intermediate visual acuity (UCIVA)
Time frame: 4-6 Months
Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative
Monocular uncorrected near visual acuity (UCNVA)
Time frame: 4-6 Months
Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative
Monocular best-corrected distance visual acuity (BCDVA) in the IC-8 IOL eye
Time frame: 4-6 Months
Mean best-corrected distance visual acuity (BCDVA) in the IC-8 IOL eye at 4-6 Months is not statistically worse than 0.2 logMAR
1 secondary outcome
Monocular and Binocular Contrast Sensitivity
Time frame: 4-6 Months
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 19 Dec 2024.
- Derived from this study: PubMed 41737854Ang RET. Visual Outcomes Following Cataract Surgery and Implantation of a Small-Aperture Intraocular Lens in Post-Refractive Surgery Patients. Clin Ophthalmol. 2026 Feb 19;20:571174. doi: 10.2147/OPTH.S571174. eCollection 2026.
- 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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IC-8 Intraocular Lens (IOL) in people with Cataract and Presbyopia, run by AcuFocus, Inc. at 2 sites in 2 countries.
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 9 inclusion and 12 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 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Philippines, 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 uncorrected distance visual acuity (UCDVA) (time frame: 4-6 Months). 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?
On the ClinicalTrials.gov record for NCT05574270, which also lists 1 linked publication.
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 19 Dec 2024.