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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
A small aperture extended depth of focus hydrophobic acrylic intraocular lens.
Asian Eye Institute
Makati City, Philippines
Singapore National Eye Centre (SNEC); Singapore Eye Research Institute (SERI)
Singapore, Singapore
Monocular uncorrected distance visual acuity (UCDVA)
Mean acuity from the IC-8 IOL eye at 4-6 Months is statistically better compared to preoperative
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 4-6 Months
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.
Time frame: 4-6 Months
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