IC-8 Apthera IOL New Enrollment Post Approval Study

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Bausch & Lomb Incorporated
Study ID
NCT06060041
Status
Recruiting
Apply to this trial

Conditions

  • Cataract
  • Posterior Capsule Opacification
  • Presbyopia

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Study Details

The purpose of this study is to verify the post-market safety of the IC-8 Apthera IOL after the treatment of posterior capsular opacification (PCO), an expected complication related to IC-8 Apthera IOL implantation.

Key Dates

First listed
Sep 29, 2023
Start date
Sep 8, 2023
Status verified
Jan 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
435 participants (estimated)

Arms

  • Arm: IC-8 Apthera intraocular lens (IOL) Group
    Patients previously implanted with the IC-8 Apthera intraocular lens (IOL) and who have developed posterior capsular opacification (PCO) which requires treatment with Nd:YAG laser capsulotomy.

Primary Outcome Measure

Rate of any additional Nd:YAG laser treatments beyond the initial Nd:YAG laser treatment [ Time Frame: 24 Months post IC-8 Apthera IOL Implantation ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Trinity Research Group, LLCDothanAlabama36301-
Feinerman Vision CenterNewport BeachCalifornia92663
OD
Argus Research CenterCape CoralFlorida33909-
Stephenson Eye AssociatesVeniceFlorida34285-
Virdi Eye Clinic and Laser Vision CenterRock IslandIllinois61201-
Price Vision GroupIndianapolisIndiana46260-
Grene Vision GroupWichitaKansas67206-
Oakland EyeBirminghamMichigan48009-
Vance Thompson Vision - OmahaOmahaNebraska68137-
Eye Associates of New JerseyDoverNew Jersey07801-
Northern New Jersey Eye InstituteSouth OrangeNew Jersey07079-
Ophthalmic Partners, PCBala-CynwydPennsylvania19004-
Berkeley Eye CenterSugar LandTexas77478-
Utah Eye CentersBountifulUtah84010-

Find similar trials in Dothan, AL

By research site
Trinity Research Group, LLC· Dothan, ALFeinerman Vision Center· Newport Beach, CAArgus Research Center· Cape Coral, FLStephenson Eye Associates· Venice, FLVirdi Eye Clinic and Laser Vision Center· Rock Island, ILPrice Vision Group· Indianapolis, IN

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