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Recruiting NCT06060041

IC-8 Apthera IOL New Enrollment Post Approval Study

— Observational Cataract Presbyopia Posterior Capsule Opacification

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cataract, Presbyopia, Posterior Capsule Opacification. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The purpose of this study is 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 Apthera IOL implantation.

Detailed description

Prospective, multi-center, 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. All subjects will undergo approximately 6 study visits and will be followed 24 months post IC-8 Apthera IOL implantation. There is one study group: subjects previously implanted with the IC-8 Apthera IOL and who have developed posterior capsular opacification (PCO) which requires treatment with Nd:YAG laser capsulotomy.

Primary outcome measures

  • Rate of any additional Nd:YAG laser treatments beyond the initial Nd:YAG laser treatment [Time frame: 24 Months post IC-8 Apthera IOL Implantation]
  • Nd:YAG laser treatment outcome and/or complications [Time frame: 24 Months post IC-8 Apthera IOL Implantation]
  • IOL related assessments [Time frame: 24 Months post IC-8 Apthera IOL implantation]
  • Rates of Secondary Surgical Interventions (SSIs) [Time frame: 24 Months post IC-8 Apthera IOL implantation]
  • Rates of other serious adverse events [Time frame: 24 Months post IC-8 Apthera IOL implantation]
  • Rates of ocular adverse events [Time frame: 24 Months post IC-8 Apthera IOL implantation]
  • Rates of subjective visual disturbances per the Quality of Vision (QoV) Questionnaire [Time frame: 24 Months post IC-8 Apthera IOL implantation]
  • Rates of subjective visual disturbances per the Small Aperture Patient Questionnaire (SAPQ) [Time frame: 24 Months post IC-8 Apthera IOL implantation]

Eligibility criteria

Inclusion criteria

  • 22 years of age or older, any race and any gender;
  • Posterior capsule opacification (PCO) requiring treatment in the IC-8 Apthera IOL eye
  • Able to comprehend and have signed a statement of informed consent;
  • Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits;
  • Clear intraocular media in both eyes;
  • Preoperative corneal astigmatism ≤1.5 D in the IC-8 Apthera IOL eye prior to IC-8 Apthera implantation;
  • Prior IC-8 Apthera IOL implantation in one eye and a monofocal/monofocal toric IOL in the other eye in accordance with the directions for use (DFU) for each IOL.

Exclusion criteria

  • Pharmacologically dilated pupil size less than 7.0 mm in the IC-8 Apthera IOL eye;
  • Irregular astigmatism in either eye;
  • History of retinal disease;
  • Active or recurrent anterior segment pathology;
  • Presence of ocular abnormalities;
  • Diagnosis of dry eye in which patients are unable to maintain eye comfort or adequate vision even with dry eye treatment;
  • Previous corneal or intraocular surgery, except cataract surgery;
  • History of ocular trauma or ocular conditions expected to require retinal laser treatment or other surgical intervention;
  • Acute, chronic or uncontrolled systemic disease that would, in the opinion of the investigator, confound the outcomes of the study;
  • Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with hormonal fluctuation that could lead to refractive changes and dry eye;
  • Concurrent participation or participation in any clinical trial up to 30 days prior to the first visit in the study.
  • Subjects who plan to be traveling, relocating or otherwise unavailable to attend any of the visits

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 14 centers
  • Trinity Research Group, LLC — Dothan
  • Feinerman Vision Center — Newport Beach
  • Argus Research Center — Cape Coral
  • Stephenson Eye Associates — Venice
  • Virdi Eye Clinic and Laser Vision Center — Rock Island
  • Price Vision Group — Indianapolis
  • Grene Vision Group — Wichita
  • Oakland Eye — Birmingham
  • … and 6 more centers

Identifiers

NCT: NCT06060041 · SAIL-101-PAS2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗