PMCF Study of Preloaded Trifocal IOL

NCT ID: NCT04884178

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-23
• Study Completion Date: 2023-08-22

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.

Detailed Description

This study is a single-arm unmasked clinical evaluation study of safety, effectiveness and patient satisfactions of the Trifocal Intraocular Lens after successful bilateral cataract surgery. Subjects will be assessed pre-operative, operative date and at 1-2 days, 1-2 weeks, 1-2 months, 3-4 months and 6 months post-operative. Clinical evaluations will include probability of adverse events, patient satisfaction questionnaire, as well as measurements of monocular and bilateral far, intermediate and near visual acuity as a result of Trifocal Lens performance, etc.

Conditions

Cataract

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trifocal Preloaded IOL Delivery System

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

Group Type: EXPERIMENTAL

Trifocal Preloaded IOL Delivery System

Intervention Type: 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.

Interventions

Trifocal Preloaded IOL Delivery System

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.

Intervention Type: DEVICE

Other Intervention Names

Asqelio Trifocal; TFPIO130Y; TFLIO130; aspicio Trifocal; PTF60Y; TF60

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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
• Chronic sever uveitis
• Pregnant or lactating
• Previous retinal detachment
• Previous corneal transplant
• Concurrent participation in another drug or device investigation
• May be expected to require other ocular surgery during the study

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AST Products, Inc.

INDUSTRY

Sponsor Role: collaborator

ICARES Medicus, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yih-Shiou Hwang, Dr.

Role: PRINCIPAL_INVESTIGATOR

Chang Gung Memorial Hospital

Locations

Chang Gung Memorial Hospital, Linkou

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

CPRO-000001

Identifier Type: -

Identifier Source: org_study_id