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Completed

NCT Number: NCT01818115

Safety and Efficacy Trial to Evaluate the Hydrus(TM) Implant in Subjects Undergoing Cataract Surgery.

The objective of this study is to demonstrate the ability of the Hydrus Implant to lower intraocular pressure in glaucoma patients undergoing cataract surgery.

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Key information

Conditions

Primary Open Angle Glaucoma Cataract Unilateral Pending Extraction Eye Diseases Glaucoma Glaucoma, Open Angle, Pseudo-exfoliative Glaucoma, Open-Angle Ocular Hypertension

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

See Central Contact, Frankfurt, Germany

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About this study

This is a post-market, prospective, single-masked, randomized, controlled, multicenter clinical trial comparing Cataract Extraction (CE) surgery + Hydrus Implant vs CE surgery alone for the reduction of intraocular pressure (IOP) in patients with a positive diagnosis for open angle glaucoma (POAG) or pseudoexfoliative glaucoma. Eligible patients will be scheduled for cataract surgery. At the time of the procedure, qualified subjects will be randomized into 1 of 2 treatment groups: Hydrus Implant with cataract surgery or cataract surgery alone. Post-operative follow up will be conducted at regular intervals.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of Primary Open Angle Glaucoma or Pseudoexfoliative Glaucoma.
  • Operable, age-related cataract eligible for phacoemulsification.

Exclusion criteria

  • Closed Angle and narrow angle forms of Glaucoma.
  • Other Secondary Glaucoma, (such as neovascular, uveitic, traumatic, steroid induced, lens induced); glaucoma associated with increase episcleral venous pressure; congenital or developmental glaucoma.

Treatment and study plan

Hydrus Implant

Device

IOL placement

Procedure

Primary outcomes

  1. Difference in proportion of subjects with 20% reduction in mean diurnal Intraocular Pressure (IOP) at 24 months following the wash-out of all glaucoma medications.

    Time frame: 24 months

    The 24 month diurnal IOP will be compared to the baseline value and a % change will be determined for each subject. A 20% drop in diurnal IOP is a successful response to treatment.

Secondary outcomes

  1. Reduction in mean washed out IOP at 24 months

    Time frame: 24 months

    The mean diurnal IOP for each subject will be calculated and the sorted by group. The group average IOP will be compared to in-group baseline and between groups at the follow up time point.

  2. Change in Best-corrected Visual Acuity (BCVA) from baseline to 12 months as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart.

    Time frame: 12 months

    A 24 month visit will be conducted to confirm 12 month findings.

  3. The proportion of eyes with IOP >5 mmHg to ≤19 mmHg following terminal washout.

    Time frame: 12 months

    A 24 month visit will be conducted to confirm 12 month findings.

  4. Diurnal IOP at 12 months following washout

    Time frame: 12 months

    A 24 month visit will be conducted to confirm 12 month findings

Sponsors and collaborators

Lead sponsor

Ivantis, Inc.

Industry

Registry information

Official study title

A Prospective, Multi-Center, Randomized Controlled Trial to Evaluate the Safety and Effectiveness of the Hydrus Implant for Lowering Intraocular Pressure in Glaucoma Patients Undergoing Cataract Surgery.

Acronym: Hydrus II

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Mar 26, 2013
Registry last updated
Feb 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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