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| General |
| Study Status |
Delayed |
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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| Clinical Trial Number(s) |
NCT03633695
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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 |
| Interim Results |
Safety Results:
A total of three Adverse Events have been reported for this study. One was determined to be serious, but unrelated to the device or study participation ("bowel sepsis"). One (“glare”) was determined to be unlikely to be related to the study procedures or YAG laser intervention.
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| Actual Number of Patients Enrolled |
17
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| Actual Number of Sites Enrolled |
15
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| Patient Follow-up Rate |
17 enrolled, 3 failed screening, 1 lost to follow-up
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