PMCF Study of Preloaded Trifocal IOL

NCT04884178 | Completed

• 1 other identifier: CPRO-000001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to evaluate the safety, effectiveness and patient satisfaction of the Trifocal Intraocular Lens after implanted to replace the natural lens following cataract removal.

Conditions

Cataract

Keywords

Cataract; Trifocal; IOL; Intraocular lens; Preloaded; Aphakic; Spectacle independence; Asqelio; aspicio; AST Products; ICARES

Outcome Measures

Primary Outcomes (4)

• Photopic monocular CDVA, 400 cm

  6 Months post second eye implantation

• Photopic monocular CIVA, 60 cm

  6 Months post second eye implantation

• Photopic monocular CNVA, 40 cm

  6 Months post second eye implantation

• Rates of adverse events vs. ISO 11979-7:2018 SPE rate

  6 Months post second eye implantation

Study Arms (1)

Trifocal Preloaded IOL Delivery System

EXPERIMENTAL

Bilateral trifocal IOLs implanted through preloaded IOL Delivery System in the capsular bag in the posterior chamber of the eye during cataract surgery

Device: Trifocal Preloaded IOL Delivery System

Interventions

Trifocal Preloaded IOL Delivery System DEVICE

UV and blue-light filtering foldable trifocal IOL with a +2.2 diopter (D) addition power of intermediate visual acuity and a +3.3 D addition power of near visual acuity. This device is approved in Taiwan.

Also known as: Asqelio Trifocal, TFPIO130Y, TFLIO130, aspicio Trifocal, PTF60Y, TF60

Trifocal Preloaded IOL Delivery System

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Bilateral cataracts: Adults, 20 years of age or older at the time of informed consent, of either gender, diagnosed with bilateral cataracts
• Desire for high post-operative spectacle independence
• Willingness to cooperate with and complete all post-operative visits
• Calculated lens power within +5.0 D and +34.0 D
• Planned cataract removal by phacoemulsification
• Clear intraocular media other that cataracts in both eyes
• Potential post-operative visual acuity of 20/25 or better
• Ability to comprehend and sign an informed consent
• Signed informed consent

You may not qualify if:

• More than 1.0 D of pre-operative corneal astigmatism
• Expected post-operative astigmatism of more than 0.75 D
• Mature/dense cataract which makes the pre-operative fundus examination difficult
• Previous ocular surgery or trauma
• Clinically significant irregular astigmatism
• Choroidal hemorrhage
• Microphthalmos
• Severe corneal dystrophy
• Medically controlled or uncontrolled glaucoma
• Clinically significant macular/RPE changes
• Concomitant severe eye disease
• Severe optic nerve atrophy
• Diabetic retinopathy, proliferative or macular edema
• Amblyopia
• Extremely shallow anterior chamber

Sponsors & Collaborators

• ICARES Medicus, Inc.: lead
• AST Products, Inc.: collaborator

Study Sites (1)

Chang Gung Memorial Hospital, Linkou

Taoyuan District, Taiwan

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Yih-Shiou Hwang, Dr.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 12, 2021
• Study Start: August 23, 2021
• Primary Completion: April 18, 2022
• Study Completion: August 22, 2023
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

TW (1)