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

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.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01818115

Acronym

Hydrus II

Enrollment

100

Registered

2013-03-26

Start date

2011-01-31

Completion date

2015-11-30

Last updated

2019-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract Unilateral Pending Extraction, Glaucoma, Open Angle, Pseudo-exfoliative, Primary Open Angle Glaucoma

Keywords

POAG, PXG, IOL Surgery, CE Surgery

Brief summary

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

Detailed description

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.

Interventions

DEVICEHydrus Implant

PROCEDUREIOL placement

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

21 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.	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

Measure	Time frame	Description
Reduction in mean washed out IOP at 24 months	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.
Change in Best-corrected Visual Acuity (BCVA) from baseline to 12 months as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) eye chart.	12 months	A 24 month visit will be conducted to confirm 12 month findings.
The proportion of eyes with IOP >5 mmHg to ≤19 mmHg following terminal washout.	12 months	A 24 month visit will be conducted to confirm 12 month findings.
Diurnal IOP at 12 months following washout	12 months	A 24 month visit will be conducted to confirm 12 month findings

Countries

Germany, Italy, Netherlands, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026