Clinical trial NCT05799950: A Real-World Evidence (RWE) Long-Term Follow-Up Study to Assess Outcomes of Alcon Monofocal Intraocular Lenses
Official title: A Real-World Evidence (RWE) Long-Term Follow-Up Study to Assess Outcomes of Alcon Monofocal Intraocular Lenses
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Aphakia
Keywords: Intraocular lens
Cataract
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-04-05
Enrollment: 230
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from clinical sites in the United States and Canada.

Brief summary: The purpose of this post-market clinical follow-up (PMCF) study is to describe the long-term safety and performance of AcrySof Single-Piece and AcrySof Multi-Piece monofocal intraocular lenses (IOLs).

Detailed description: The study includes a retrospective chart review for pre-operative, operative, and post-operative data collection, and a prospective, standard-of-care visit to collect study endpoints.

Eligibility criteria: Key Inclusion Criteria:

* Subject is implanted with one of the study IOL models between 3 and 5 years previously.
* Subject follow-up is expected to be possible during the duration of the study.
* Subject or legally authorized representative must be able to understand and sign the IRB/EC approved Informed Consent form. Minor subjects will complete an Assent Form.
* Documented medical history and required pre-operative baseline information is available for retrospective data collection.

Key Exclusion Criteria:

* Subject is participating in a separate investigational drug or device study.
* Pregnancy at the time of enrollment.

Primary outcomes:
measure: Mean monocular best corrected distance visual acuity (BCDVA)
timeFrame: Up to 3 to 5 years post operative
measure: Rate of protocol-specified ocular adverse events
timeFrame: Up to 3 to 5 years post operative
Secondary outcomes:
measure: Mean manifest refraction - Sphere
timeFrame: Up to 3-5 years postoperative
measure: Mean manifest refraction - Cylinder
timeFrame: Up to 3-5 years postoperative
measure: Mean manifest refraction - Axis
timeFrame: Up to 3-5 years postoperative
measure: Manifest refraction spherical equivalent (MRSE)
timeFrame: Up to 3-5 years postoperative
measure: Mean monocular uncorrected distance visual acuity (UCDVA)
timeFrame: Up to 3-5 years postoperative
measure: Rate of additional adverse events - Ocular
timeFrame: Up to 3-5 years postoperative
measure: Rate of device deficiencies
timeFrame: Up to 3-5 years postoperative
measure: Rate of posterior capsulotomies
timeFrame: Up to 3-5 years postoperative
Other outcomes:
Locations:
city: Burbank
country: United States
facility: Velvet Clinical Research
state: California
city: Jacksonville
country: United States
facility: Levenson Eye Associates
state: Florida
city: Rock Island
country: United States
facility: Virdi Eye Clinic
state: Illinois
city: Babylon
country: United States
facility: SightMD
state: New York
city: Austin
country: United States
facility: Texan Eye
state: Texas
city: Fort Worth
country: United States
facility: Chu Eye Institute
state: Texas
city: San Juan
country: Puerto Rico
facility: Centro Oftalmologico Metropolitano
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Lead, Surgical
role: STUDY_DIRECTOR
References: