Clinical Investigation of a Small Aperture Extended Depth of Focus Intraocular Lens in Patients With Complex Corneas
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IC-8 IOL Group A monofocal or monofocal toric IOL implanted in the first eye of a subject and the IC-8 IOL implanted in the second eye. |
Device: IC-8 Intraocular Lens (IOL)
A small aperture extended depth of focus hydrophobic acrylic intraocular lens.
Other Names:
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Outcome Measures
Primary Outcome Measures
- Monocular uncorrected distance visual acuity (UCDVA) [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) [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) [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 [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
Secondary Outcome Measures
- Monocular and Binocular Contrast Sensitivity [4-6 Months]
Photopic and Mesopic contrast sensitivity (with and without glare) in each eye and both eyes will be analyzed. No success criterion or hypothesis testing.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Minimum 22 years of age;
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Able to comprehend and have signed a statement of informed consent;
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Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s);
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Planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber IOL implantation;
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Planned cataract removal or planned clear lens exchange in both eyes
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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
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Having clear central cornea
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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).
Exclusion Criteria:
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Requiring an IC-8 IOL outside the available spherical power range;
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Pharmacologically dilated pupil size less than 6 mm in either eye;
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Preoperative corneal astigmatism >1.50 diopters in the eye to be implanted with the IC-8 IOL;
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Active or recurrent anterior segment pathology;
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Presence of ocular abnormalities or conditions (other than corneal irregularities) as specified by the protocol;
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Congenital bilateral cataracts;
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Previous ocular surgery as specified by the protocol;
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Conditions requiring planned ocular surgical intervention;
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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;
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Use of systemic or ocular medications as specified by the protocol;
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Concurrent participation or participation in any clinical investigation up to 30 days prior to preoperative visit;
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Patient is pregnant or nursing.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Asian Eye Institute | Makati City | Philippines | ||
| 2 | Singapore National Eye Centre (SNEC); Singapore Eye Research Institute (SERI) | Singapore | Singapore |
Sponsors and Collaborators
- AcuFocus, Inc.
Investigators
- Study Director: Magda Michna, Ph.D., AcuFocus, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IC8-204-EXP2