A Real-World Evidence (RWE) Long-Term Follow-Up Study to Assess Outcomes of Alcon Monofocal Intraocular Lenses

Aphakia Clinical Trial

Official title:

A Real-World Evidence (RWE) Long-Term Follow-Up Study to Assess Outcomes of Alcon Monofocal Intraocular Lenses

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05799950
• Other study ID #: ILB609-N001
• Status: Enrolling by invitation
• Start date: August 28, 2023
• Est. completion date: November 2024

Study information

• Verified date: March 2024
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 230
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Aphakia

Intervention

Device:
• AcrySof single-piece IOL
Acrylic single-piece intraocular lens placed in the capsular bag in the posterior chamber of the eye during cataract surgery as a replacement for the natural crystalline lens.
• AcrySof multi-piece IOL
Acrylic multi-piece intraocular lens placed in the capsular bag in the posterior chamber of the eye during cataract surgery as a replacement for the natural crystalline lens.

Locations

Country	Name	City	State
Puerto Rico	Centro Oftalmologico Metropolitano	San Juan
United States	Texan Eye	Austin	Texas
United States	SightMD	Babylon	New York
United States	Velvet Clinical Research	Burbank	California
United States	Chu Eye Institute	Fort Worth	Texas
United States	Levenson Eye Associates	Jacksonville	Florida
United States	Virdi Eye Clinic	Rock Island	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean monocular best corrected distance visual acuity (BCDVA)	Retrospectively, the subject's medical records will be reviewed for assessments of BCDVA. Prospectively, visual acuity will be assessed for each eye individually with correction in place using letter charts placed at a distance of 6 meters (or 4 meters adjusted for infinity) from the subject. BCDVA will be reported in logarithm minimum angle of resolution (logMAR), where a logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight) and lower logMAR values indicate better visual acuity.	Up to 3 to 5 years post operative
Primary	Rate of protocol-specified ocular adverse events	The subject's medical records will be reviewed for medical conditions. Medical conditions that started after initial exposure to the study model IOLs will be captured as adverse events. The following adverse events are pre-specified for this outcome measure: Cystoid macular edema (CME); Hypopyon; Endophthalmitis; Lens dislocation; Pupillary block; Retinal detachment; Secondary surgical interventions	Up to 3 to 5 years post operative
Secondary	Mean manifest refraction - Sphere	Retrospectively, the subject's medical records will be reviewed for manifest refraction assessments. Prospectively, the subject will be manually refracted to his/her best correction using a phoropter. The spherical component will be measured in diopters.	Up to 3-5 years postoperative
Secondary	Mean manifest refraction - Cylinder	Retrospectively, the subject's medical records will be reviewed for manifest refraction assessments. Prospectively, the subject will be manually refracted to his/her best correction using a phoropter. The cylindrical component will be measured in diopters.	Up to 3-5 years postoperative
Secondary	Mean manifest refraction - Axis	Retrospectively, the subject's medical records will be reviewed for manifest refraction assessments. Prospectively, the subject will be manually refracted to his/her best correction using a phoropter. The axial component will be measured in degrees.	Up to 3-5 years postoperative
Secondary	Manifest refraction spherical equivalent (MRSE)	Retrospectively, the subject's medical records will be reviewed for manifest refraction assessments. Prospectively, the subject will be manually refracted to his/her best correction using a phoropter. MRSE will be calculated as [Sphere minus (cylinder divided by 2)] and reported in diopters.	Up to 3-5 years postoperative
Secondary	Mean monocular uncorrected distance visual acuity (UCDVA)	Visual acuity will be assessed for each eye individually with no correction in place using letter charts placed at a distance of 6 meters (or 4 meters adjusted for infinity) from the subject. UCDVA will be measured in logarithm minimum angle of resolution (logMAR). A logMAR value of 0 equates to 20/20 Snellen visual acuity (normal distance eyesight), with lower logMAR values indicating better visual acuity.	Up to 3-5 years postoperative
Secondary	Rate of additional adverse events - Ocular	The subject's medical records will be reviewed for medical conditions. Medical conditions that started after initial exposure to the study model IOLs will be captured as adverse events. This outcome measure will include all ocular adverse events other than the protocol-specified adverse events.	Up to 3-5 years postoperative
Secondary	Rate of device deficiencies	The subject's medical records will be reviewed for device deficiencies. Examples of device deficiencies include the following: Failure to meet product specifications (e.g., incorrect IOL power); IOL defect; Broken IOL optic; Broken IOL haptic; Scratched IOL optic; Unsealed device packaging; Suspected product contamination; Lack of performance. A device deficiency may or may not be associated with subject harm.	Up to 3-5 years postoperative
Secondary	Rate of posterior capsulotomies	Posterior capsulotomy is surgery performed on the back side of the capsular bag in the eye. A laser is used to make an opening in the cloudy capsule to allow light to pass through again for clear vision. The subject's medical records will be reviewed for the occurrence of posterior capsulotomy.	Up to 3-5 years postoperative