Clinical trial NCT06060041: IC-8 Apthera IOL New Enrollment Post Approval Study
Official title: IC-8 Apthera IOL New Enrollment Post Approval Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cataract
Presbyopia
Posterior Capsule Opacification
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2023-09-29
Enrollment: 435
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential study subjects will be recruited from patients previously implanted with the IC-8 Apthera intraocular lens (IOL) and who have developed posterior capsular opacification in the IC-8 Apthera IOL eye which requires treatment with Nd:YAG laser capsulotomy

Brief summary: 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.

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

Primary outcomes:
measure: Rate of any additional Nd:YAG laser treatments beyond the initial Nd:YAG laser treatment
timeFrame: 24 Months post IC-8 Apthera IOL Implantation
measure: Nd:YAG laser treatment outcome and/or complications
timeFrame: 24 Months post IC-8 Apthera IOL Implantation
measure: IOL related assessments
timeFrame: 24 Months post IC-8 Apthera IOL implantation
measure: Rates of Secondary Surgical Interventions (SSIs)
timeFrame: 24 Months post IC-8 Apthera IOL implantation
measure: Rates of other serious adverse events
timeFrame: 24 Months post IC-8 Apthera IOL implantation
measure: Rates of ocular adverse events
timeFrame: 24 Months post IC-8 Apthera IOL implantation
measure: Rates of subjective visual disturbances per the Quality of Vision (QoV) Questionnaire
timeFrame: 24 Months post IC-8 Apthera IOL implantation
measure: Rates of subjective visual disturbances per the Small Aperture Patient Questionnaire (SAPQ)
timeFrame: 24 Months post IC-8 Apthera IOL implantation
Secondary outcomes:
Other outcomes:
measure: Nd:YAG laser technique details and/or settings
timeFrame: PCO treatment visit (during the Nd:YAG laser procedure)
measure: Investigator opinion of ease of YAG procedure
timeFrame: PCO treatment visit (during the Nd:YAG laser procedure)
measure: Mean monocular and binocular uncorrected distance visual acuity (UCDVA), uncorrected intermediate visual acuity (UCIVA) and uncorrected near visual acuity (UCNVA)
timeFrame: 24 Months post IC-8 Apthera IOL implantation
measure: Mean monocular and binocular distance corrected distance visual acuity (DCDVA), distance corrected intermediate visual acuity (DCIVA) and distance corrected near visual acuity (DCNVA)
timeFrame: 24 Months post IC-8 Apthera IOL implantation
measure: Rates of device deficiencies
timeFrame: 24 Months post IC-8 Apthera IOL implantation
measure: Rates of loss of 10 or more Early Treatment Diabetic Retinopathy Study (ETDRS) letters of best corrected distance visual acuity (BCDVA)
timeFrame: 24 Months post IC-8 Apthera IOL implantation
Locations:
city: Dothan
country: United States
facility: Trinity Research Group, LLC
state: Alabama
city: Newport Beach
country: United States
facility: Feinerman Vision Center
state: California
city: Cape Coral
country: United States
facility: Argus Research Center
state: Florida
city: Rock Island
country: United States
facility: Virdi Eye Clinic and Laser Vision Center
state: Illinois
city: Indianapolis
country: United States
facility: Price Vision Group
state: Indiana
city: Birmingham
country: United States
facility: Oakland Eye
state: Michigan
city: Omaha
country: United States
facility: Vance Thompson Vision - Omaha
state: Nebraska
city: Dover
country: United States
facility: Eye Associates of New Jersey
state: New Jersey
city: South Orange
country: United States
facility: Northern New Jersey Eye Institute
state: New Jersey
city: Bala-Cynwyd
country: United States
facility: Ophthalmic Partners, PC
state: Pennsylvania
city: Sugar Land
country: United States
facility: Berkeley Eye Center
state: Texas
city: Bountiful
country: United States
facility: Utah Eye Centers
state: Utah
Study officials:
References: