Cataract, Irregular Astigmatism, Presbyopia
Conditions
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.
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.
Interventions
DEVICEIC-8 Intraocular Lens (IOL)
A small aperture extended depth of focus hydrophobic acrylic intraocular lens.
Sponsors
AcuFocus, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Minimum 22 years of age; 2. Able to comprehend and have signed a statement of informed consent; 3. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s); 4. Planned crystalline lens removal by phacoemulsification, with or without femtosecond laser-assisted extraction, and posterior chamber IOL implantation; 5. Planned cataract removal or planned clear lens exchange in both eyes 6. Potential for postoperative best-corrected distance visual acuity (BCDVA) of 20/32 or better after crystalline lens removal; 7. Having complex corneas with irregular astigmatism 8. Having clear central cornea 9. 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
1. Requiring an IC-8 IOL outside the available spherical power range; 2. Pharmacologically dilated pupil size less than 6 mm in either eye; 3. Preoperative corneal astigmatism \>1.50 diopters in the eye to be implanted with the IC-8 IOL; 4. Active or recurrent anterior segment pathology; 5. Presence of ocular abnormalities or conditions (other than corneal irregularities) as specified by the protocol; 6. Congenital bilateral cataracts; 7. Previous ocular surgery as specified by the protocol; 8. Conditions requiring planned ocular surgical intervention; 9. 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; 10. Use of systemic or ocular medications as specified by the protocol; 11. Concurrent participation or participation in any clinical investigation up to 30 days prior to preoperative visit; 12. Patient is pregnant or nursing.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Philippines, Singapore
Outcome results
None listed