Artisan Aphakia Intraocular Lens for Aphakia

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
AphakiaArtisan Aphakia Intraocular Lens - Device
Eligibility
2 - 21
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test the safety and effectiveness of a new lens to treat aphakia (a condition where the eye's natural lens is missing) in children.

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 5 years follow up

5 years follow up
Best corrected distance visual acuity at 12 months postoperative

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

1 Treatment Group

Artisan Aphakia Intraocular Lens
1 of 1

Experimental Treatment

300 Total Participants · 1 Treatment Group

Primary Treatment: Artisan Aphakia Intraocular Lens · No Placebo Group · Phase 3

Artisan Aphakia Intraocular Lens
Device
Experimental Group · 1 Intervention: Artisan Aphakia Intraocular Lens · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years follow up

Who is running the clinical trial?

Ophtec USALead Sponsor
1 Previous Clinical Trials
300 Total Patients Enrolled
1 Trials studying Aphakia
300 Patients Enrolled for Aphakia
Fred WassenburgStudy DirectorSponsor GmbH
1 Previous Clinical Trials
300 Total Patients Enrolled
1 Trials studying Aphakia
300 Patients Enrolled for Aphakia
Abraham FarhanStudy DirectorSponsor GmbH
1 Previous Clinical Trials
300 Total Patients Enrolled
1 Trials studying Aphakia
300 Patients Enrolled for Aphakia

Eligibility Criteria

Age 2 - 21 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
People in the age group of 2 to 21 years are considered as minors
A compromised capsular bag may prevent the implantation of a standard posterior IOL.
You or your parent/guardian must be able to follow the study schedule and meet all requirements.
Form This means that the person who will be legally responsible for the subject must be able to agree to the study and sign the form
You have a visually significant cataract or need IOL replacement surgery.