Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a prospective, multicenter, parallel groups, non-interventional, examiner masked, comparative clinical study. Patients that participated in previous Hoya studies, and patients previous implanted with Hoya non-toric monofocal IOLs (sub-study only) will be enrolled in the study. The sample size for this study is based on demonstrating the non-inferiority of the mean distance-corrected intermediate visual acuity (DCIVA) in Group 1 (Site 1) compared with Group 2 (Site 2).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects to participate in main study only | Evaluate visual outcomes in extension cohort |
| |
| Subjects to participate in exploratory sub-study only | Evaluate visual outcomes in extension cohort |
| |
| Subjects to participate in both main and sub-study | Evaluate visual outcomes in extension cohort |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | This clinical investigation is non-interventional and does not involve the use of any new medical device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance-corrected intermediate visual acuity | The primary objective of this study is to evaluate whether visual performance in eyes from Group 1 (Site 1) is non-inferior to eyes from Group 2 (Site 2) with respect to distance-corrected intermediate visual acuity (DCIVA), using a predefined non-inferiority margin of 0.10 logMAR. | Up to 15 days |
| Measure | Description | Time Frame |
|---|---|---|
| Corrected distance visual acuity and distance-corrected near acuity | The secondary objective of the study is to evaluate whether visual performance in eyes from Group 1 (Site 1) is non-inferior to eyes from Group 2 (Site 2) with respect to corrected distance visual acuity (CDVA) and distance-corrected near acuity (DCNVA), using a non-inferiority margin of 0.10 logMAR. | Up to 15 days |
Not provided
Inclusion Criteria:
Main study:
Exploratory sub-study:
1. Additional inclusion criteria: Pseudophakic eyes implanted with one of the IOLs in one eye from 3 previous IOL studies
Exclusion Criteria:
Main study:
Exploratory sub-study:
1. Additional exclusion criteria: Pseudophakic eyes with oblique residual astigmatism.
Not provided
Not provided
Not provided
The study population includes subjects who have previously undergone intraocular lens implantation in prior studies. Subjects must have clear intraocular media, good visual acuity, and be able to provide informed consent and complete study procedures.
For the exploratory sub-study, a subset of subjects with eyes from multiple prior IOL studies will be included, excluding those with oblique residual astigmatism.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Srividhya Medical Monitor | Contact | +1-909-680-3900 | srividhya.vilupuru@hoya.com |
| Name | Affiliation | Role |
|---|---|---|
| Srividhya Vilupuru | Hoya Surgical Optics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peregrine Eye Laser Institute | Recruiting | Manila | Philippines |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided