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Safety and Efficacy of iDose® TR With Cataract Surgery vs. Cataract Surgery Alone

Safety and Efficacy of iDose® TR With Cataract Surgery vs. Cataract Surgery Alone

Recruiting
45 years and older
All
Phase 4
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Overview

This trial will evaluate the safety and IOP -lowering efficacy of administering an iDose TR (travoprost intracameral implant) in conjunction with cataract surgery compared to cataract surgery alone

Description

This is a Phase 4 randomized, double-masked, parallel group trial designed to evaluate the safety and IOP-lowering efficacy of administering iDose TR (travoprost intracameral implant 75 mcg) in conjunction with uncomplicated cataract surgery (phacoemulsification with a posterior chamber intraocular lens) compared to uncomplicated cataract surgery alone, in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

Eligibility

Inclusion Criteria:

  • Cataract diagnosis: clinically significant age-related cataract eligible for phacoemulsification in the study eye.
  • OAG or OHT diagnosis: either OAG (i.e. primary, pseudoexfoliation, or pigmentary glaucoma) or OHT in the study eye (i.e., eye to undergo cataract surgery)

Exclusion Criteria:

  • Active corneal inflammation or edema.
  • Retinal disorders not associated with glaucoma.

Study details
    Glaucoma
    Open-angle
    Ocular Hypertension (OHT)
    Phacoemulsification Cataract Surgery

NCT06848946

Glaukos Corporation

15 October 2025

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