Cataract Clinical Trial
Official title:
Clinical Investigation of a Small Aperture Extended Depth of Focus Intraocular Lens in Patients With Complex Corneas
Verified date | December 2022 |
Source | AcuFocus, Inc. |
Contact | Laura Schall |
Phone | 336-306-0587 |
lschall[@]acufocus.com | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | January 12, 2024 |
Est. primary completion date | January 12, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 22 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Philippines | Asian Eye Institute | Makati City | |
Singapore | Singapore National Eye Centre (SNEC); Singapore Eye Research Institute (SERI) | Singapore |
Lead Sponsor | Collaborator |
---|---|
AcuFocus, Inc. |
Philippines, Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Monocular uncorrected distance visual acuity (UCDVA) | Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative | 4-6 Months | |
Primary | Monocular uncorrected intermediate visual acuity (UCIVA) | Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative | 4-6 Months | |
Primary | Monocular uncorrected near visual acuity (UCNVA) | Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative | 4-6 Months | |
Primary | 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 | 4-6 Months | |
Secondary | 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. | 4-6 Months |
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