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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P210005 / PAS002 |
| Date Original Protocol Accepted |
09/20/2022
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| Date Current Protocol Accepted |
12/02/2022
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| Study Name |
New Enrollment Study-IC-8 Apthera IOL
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| Device Name |
IC-8 Apthera Intraocular Lens (IOL)
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
No Control
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| Analysis Type |
Descriptive
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Objective: To verify the post-market safety of the IC-8 Apthera IOL after the treatment of posterior capsular opacification (PCO), an expected complication related to IC-8 IOL implantation.
Design: Prospective, multicenter, single-group, non-randomized new enrollment post approval study to assess the post-market safety of the IC-8 Apthera IOL after Nd:YAG laser capsulotomy following sufficient surgeon training of the sponsor-recommended standardized Nd:YAG laser capsulotomy technique.
The study will be conducted in two phases, Phase A and Phase B. Phase A will occur prior to initiating enrollment for Phase B. The objective of Phase A is to develop a clinician-focused training program that ensures proper training for the treatment of PCO, an expected complication related to IC-8 Apthera IOL implantation. Phase A consists of non-interventional, qualitative research to create the clinician-focused training program.
Phase B, which this protocol outlines, will begin after development of the surgical training plan in Phase A is completed and has been accepted by FDA. The objective of Phase B will be to assess the safety of the IC-8 Apthera IOL after the treatment of posterior capsular opacification (PCO) with Nd:YAG laser
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| Study Population |
The study population will include subjects previously implanted with the IC-8 Apthera IOL in one eye and a monofocal/monofocal toric IOL in the fellow eye in accordance with the Directions for Use (DFU) for the IC-8 Apthera IOL, who meet all inclusion/exclusion criteria, and who have developed posterior capsular opacification (PCO) following IC-8 Apthera IOL implantation that requires treatment.
A total of 483 subjects will be consented and enrolled in the study to ensure 435 subjects are available to complete the two-year (up to 25-months) follow-up. Each investigator should enroll approximately 20-30 subjects, and no investigator may enroll more than 25% of the intended total enrollment.
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| Sample Size |
No. of subjects: 435
The sample size calculation for the study is based on a desired precision around the point estimate for the explant rate.
Assuming an explant rate of 0.5%, a 95% exact (Clopper-Pearson) upper confidence limit with precision of 1.0% (i.e., an upper CL of 1.5%) would require 435 subjects. Taking into account 10% attrition rate over 24 months, the study should enroll 483 subjects that have developed PCO and require treatment to ensure a minimum of 435 subjects are available to complete the 2-year (approximately 24-months) follow-up.
No. of sites: 15 – 20
Sites location: US
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| Key Study Endpoints |
Co-Primary Safety Endpoints:
The co-primary safety endpoints and/or parameters include the following: the rate of any additional Nd:YAG treatments beyond the initial Nd:YAG treatment, Nd:YAG outcome and/or complications, IOL-related assessments (including IC-8 Apthera IOL mask appearance and indication of any Nd:YAG damage), rates of secondary surgical interventions (SSI), rates of other serious ocular adverse events (as described in ISO 11979-7 historical grid), rate of each ocular adverse event (including but not limited to the adverse events described in the ISO 11979-7 historical grd), and rates of subjective visual disturbances.
Additional Endpoints:
Other parameters that will be collected in the study include but are not limited to the following: Nd:YAG laser technique details and/or settings, Nd:YAG difficulty; monocular and binocular best-corrected visual acuities; uncorrected visual acuities; rates of device deficiencies.
Patient-reported outcomes (PROs) will be assessed with the Quality of Vision (QoV) instrument (McAlinden 2010) and the Small Aperture Patient Questionnaire (SAPQ).
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| Follow-up Visits and Length of Follow-up |
24 months
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
5
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| Actual Number of Sites Enrolled |
13
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| Patient Follow-up Rate |
1 subject had been reported lost to follow-up
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| Final Safety Findings |
1 adverse event was reported; it was deemed "moderate severity" and was "not related."
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