PMCF Study of Preloaded Trifocal IOL

Cataract Clinical Trial

Official title:

Post-Market Clinical Follow-up Study of Preloaded Trifocal IOL Delivery System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04884178
• Other study ID #: CPRO-000001
• Status: Completed
• Phase: N/A
• Start date: August 23, 2021
• Est. completion date: August 22, 2023

Study information

• Verified date: April 2024
• Source: ICARES Medicus, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 22, 2023
• Est. primary completion date: April 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital, Linkou	Taoyuan

Sponsors (2)

Lead Sponsor	Collaborator
ICARES Medicus, Inc.	AST Products, Inc.

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Photopic monocular CDVA, 400 cm		6 Months post second eye implantation
Primary	Photopic monocular CIVA, 60 cm		6 Months post second eye implantation
Primary	Photopic monocular CNVA, 40 cm		6 Months post second eye implantation
Primary	Rates of adverse events vs. ISO 11979-7:2018 SPE rate		6 Months post second eye implantation