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The purpose of this multi-center clinical trail is to determine the safety and efficacy of the iSert 251 for the correction of aphakia.
This study evaluated the safety and effectiveness of the Hoya Surgical Optics iSert Model 251 IOL following primary implantation for the visual correction of aphakia in adults in whom the cataractous lens has been removed by phacoemulsification. Results from this prospective, multicenter clinical trial will be used to support a PMA supplement for the iSert® 251 IOL.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational intraocular lens | Experimental | iSert 251 intraocular lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iSert 251 intraocular lens | Device | aphakic intraocular lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Acuity | BEST Spectacle-Correction (ETDRS) Distance Visual Acuity | 4 to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complications and Adverse Events | Number of Participants with Complications or Adverse Events | 4 to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
Eligibility criteria not complete. Contact Hoya Surgical Optics, Inc. for more information.
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| Name | Affiliation | Role |
|---|---|---|
| Kees den Besten | Hoya Surgical Optics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schwartz Laser Eye Center | E. Shea Blvd, Suite C101 | Arizona | 85260 | United States | ||
| Katzen Eye Care and Laser Center |
Subject's eligibility was determined at the preoperative visit. All subject met inclusion/exclusion criteria.
Subjects who were >50 years of age, either sex, and any race were eligible for this study. Diagnosis of cataracts in one or both eyes.
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| ID | Title | Description |
|---|---|---|
| FG000 | iSert 251: iSert 251 Intraocular Lens | Implantation with the iSert® 251 Intraocular lens |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Boynton Beach |
| Florida |
| 33426 |
| United States |
| Center for Excellence in Eye Care | Miami | Florida | 33176 | United States |
| Eye Surgeons of Indiana | Indianapolis | Indiana | 46256 | United States |
| Eye Health Vision Centers | North Dartmouth | Massachusetts | 02747 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | iSert® 251 Intraocular Lens | Population Description: A total of 125 subjects were implanted with the iSert® IOL. Data analysis for baseline characteristics was completed on these 125 subjects. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | A total of 125 subjects were implanted with the iSert® IOL. Data analysis for baseline characteristics was completed on these 125 subjects. | Number | participants |
| |||||||||||||||||||||||||
| Sex/Gender, Customized | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Visual Acuity | BEST Spectacle-Correction (ETDRS) Distance Visual Acuity | 125 subjects enrolled in the study, 121 were examined at the Form 4 and the remaining four (3.2%) subjects missed the Form 4 visit but were examined later. 121 subjects were evaluated for primary and secondary effectiveness and safety outcomes. | Posted | Number | subjects | 4 to 6 months |
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| Secondary | Complications and Adverse Events | Number of Participants with Complications or Adverse Events | Posted | Number | participants | 4 to 6 months |
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4-6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | iSert 251: iSert 251 Intraocular Lens | Subjects who underwent phacoemulsification cataract extraction surgery who were implanted with the iSert aphakic intraocular lens. | 0 | 125 | 0 | 125 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kees den Besten, Vice President Global Quality, Regulatory Affairs, and Clinical Research | Hoya Surgical Optics, Inc. | +65 6681 0025 | kees.denbesten@HOYA.com |
| ID | Term |
|---|---|
| D001035 | Aphakia |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Title | Measurements |
|---|---|
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| ≥ 80 years of age |
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