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The purpose of this study is to evaluate visual outcomes in patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal.
This will be a prospective, non-randomized, single-arm, single-visit, single-center, clinical study in up to 40 patients previously contralaterally implanted with the IC-8 IOL at one clinical site in Singapore.
The purpose of this study is to to evaluate visual outcomes in patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal. The co-primary study endpoints are monocular uncorrected distance, intermediate, near visual acuities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IC-8 IOL Group | Visual outcomes in patients previously contralaterally implanted with the IC-8 IOL will be evaluated. |
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| Measure | Description | Time Frame |
|---|---|---|
| Monocular UCDVA | 0.3 logMAR or better | 3 Months |
| Monocular UCIVA | 0.3 logMAR or better | 3 Months |
| Monocular UCNVA | not worse than 0.3 logMAR | 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
Baseline visual acuity worse than 20/25 BCDVA in either eye;
Presence of ocular abnormalities or conditions other than corneal irregularities that could confound the study outcome(s), such as:
Previous intraocular surgery, except cataract surgery, pterygium surgery, or corneal procedures (other than corneal-cross linking);
Previous corneal cross-linking procedure with any corneal haze;
Conditions requiring planned ocular surgical intervention, except Nd:YAG capsulotomy;
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;
Patient is pregnant or nursing.
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Patients for this study will be recruited from patients with complex corneas who have been previously implanted with the IC-8 IOL after cataract removal. Anticipated study sample size of up to 40 patients will be evaluated.
Patients will be screened for eligibility, and an informed consent will be obtained from those who meet the screening criteria and are interested in participating in the study.
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| Name | Affiliation | Role |
|---|---|---|
| Magda Michna, Ph.D. | AcuFocus, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Singapore Eye Research Institute / Singapore National Eye Centre | Singapore | Singapore |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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