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This purpose of this survey study is to collect and describe clinical outcomes for the intraocular lens (IOL) delivery performance of Clareon® IOL AutonoMe™ when used in daily practice.
This study will enroll subjects who underwent prior cataract surgery with phacoemulsification and were implanted with Clareon intraocular lenses (IOLs) using the Clareon® IOL AutonoMe™ automated preloaded delivery system. Subjects will be enrolled post-operatively and followed for one year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clareon IOL AutonoMe | Prior implantation with Clareon intraocular lenses (IOLs) using the Clareon® IOL AutonoMe™ automated preloaded delivery system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clareon® IOL AutonoMe™ automated preloaded delivery system | Device | Disposable injector preloaded with the Clareon IOL for precise IOL insertion during cataract surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Best-corrected distance visual acuity | Visual acuity will be collected under well-lit conditions at a distance of five meters using a decimal visual acuity chart. | Up to Year 1 postoperative |
| Intraocular lens (IOL) delivery performance | A questionnaire will be used to retrospectively evaluate the usability of AutonoME™. The investigator will respond to 8 questions pertaining to the IOL delivery performance using a 5-point scale where 1 = very good/strongly agree and 5 = very poor/strongly disagree. | Surgery day (retrospective) |
| Difference between target refraction and postoperative subjective refraction (spherical equivalent) | Visual acuity will be collected under well-lit conditions at a distance of five meters using a decimal visual acuity chart. Subjective refraction at best corrected distance vision will be recorded and compared with target refraction determined on day of surgery. | Up to Year 1 postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects will be enrolled at approximately 20 investigative sites located in Japan.
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| Name | Affiliation | Role |
|---|---|---|
| Alcon Research | Alcon Japan, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alcon Investigative Site | Yokohama | Kanagawa | 220-0011 | Japan | ||
| Alcon Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34261986 | Derived | Oshika T, Sasaki N; Clinical Study Group on New Intraocular Lens and Delivery System. One-year multicenter evaluation of a new hydrophobic acrylic intraocular lens with hydroxyethyl methacrylate in an automated preloaded delivery system. J Cataract Refract Surg. 2022 Mar 1;48(3):275-279. doi: 10.1097/j.jcrs.0000000000000746. |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Yokkaichi |
| Mie-ken |
| 510-0085 |
| Japan |
| Alcon Investigative Site | Hashimoto | Wakayama | 648-0073 | Japan |