Safety and Efficacy of the Bi-Aspheric Monofocal IOL

Cataract Clinical Trial

Official title:

Safety and Efficacy of the Bi-Aspheric Monofocal Intraocular Lens

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06380478
• Other study ID #: CPRO-000012
• Status: Recruiting
• Start date: March 5, 2024
• Est. completion date: December 25, 2024

Study information

• Verified date: April 2024
• Source: ICARES Medicus, Inc.
• Contact: Lisa Chen
• Phone: +88636579530
• Email: lisa.phchen[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This is an observational, single-center, non-control, open-label post-marketing study. Patients implanted with an aspicio™ Monofocal Intraocular Lens will be scheduled for a follow-up visit at least 3 months after the surgery to undergo a routine basic ophthalmological examination.

Description:

This is an observational, single-center, non-control, open-label post-marketing study. Patients implanted with an aspicio™ Monofocal Intraocular Lens will be scheduled for a single visit in the facilities of Chang Gung University Hospital at least 3 months after the surgery. Patients will undergo a routine basic ophthalmological examination.

Additionally, and retrospectively, the patients' medical records will be reviewed to obtain information on visual acuity and adverse events at postoperative visit carried out 1 month after surgery.

The data corresponding to the preoperative values of corneal curvature (flat meridian, curved meridian and axes), axial length measured by biometry, visual acuity and those corresponding to the implanted IOL will also be collected from the medical records.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 25, 2024
• Est. primary completion date: December 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subjects 18 years of age or older who have been implanted with aspicio™ monofocal intraocular lens in at least 1 eye

2. Willingness to cooperate with and complete all post-operative visits

3. Ability to comprehend and sign an informed consent

Exclusion Criteria:

1. Any pathology that could reduce Visual Acuity (VA) (including amblyopia, severe corneal dystrophy, diabetic retinopathy, extremely narrow anterior chamber depth, microphthalmos, clinically significant macular/RPE changes, retinal detachment, corneal transplant, chronic sever uveitis, choroidal hemorrhage, recurrent severe inflammation of the anterior or posterior segment of unknown etiology, iris neovascularization, medically controlled or uncontrolled glaucoma, clinically significant macular degeneration, or diagnosis of pseudoexfoliation).

2. Previous ocular surgery (including YAG-laser) or trauma

3. Clinically significant irregular astigmatism

4. Concomitant severe eye disease

5. Pregnant or lactating

6. Any other ocular or systemic condition which, in the opinion of the investigator, should exclude the subject from the study

7. Concurrent participation in another drug or device investigation

8. May be expected to require other ocular surgery during the study

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• aspicio Monofocal IOL
A bi-aspheric monofocal IOL is implanted through preloaded IOL Delivery System in the capsular bag in the posterior chamber of the eye during cataract surgery

Locations

Country	Name	City	State
Taiwan	Chang Gung University Hospital	Taoyuan	Guishan District

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	CDVA	Photopic monocular best corrected distance visual acuity (CDVA), 400cm	3 months after implantation
Primary	Defocus curve	Photopic monocular defocus curve, -4.0 D ~ +2.0 D	3 months after implantation
Secondary	UDVA	Photopic monocular uncorrected distance visual acuity (UDVA), 400cm	3 months after implantation
Secondary	UIVA	Photopic monocular uncorrected intermediate visual acuity (UIVA), 60cm	3 months after implantation
Secondary	CIVA	Photopic monocular corrected intermediate visual acuity (CIVA), 60cm	3 months after implantation
Secondary	IOL glistening	IOL glistening observation	3 months after implantation
Secondary	PCO	Posterior Capsular Opacification observation	3 months after implantation
Secondary	Satisfaction questionnaire	Satisfaction questionnaire	3 months after implantation
Secondary	AE	Signs of inflammation and AEs	3 months after implantation