Alcon Hydrus Stent Implantation - Long Term Follow up After 8 Years

Official title

An Ambispective, Monocentric, Non-interventional Long-term Follow-up Trial to Evaluate the Effectiveness and Safety of the Hydrus Implant Combined With Concomitant Phacoemulsification for Lowering Intraocular Pressure (IOP) in Glaucoma Patients

Overview

The purpose of this study is to evaluate the long-term effectiveness and safety of the Hydrus implant combined with concomitant phacoemulsification for lowering intraocular pressure (IOP).Glaucoma patients often have high intraocular pressures (IOP) and need long-term IOP control to prevent loss of visual function and blindness. To date, data on the results of up to 5 years after Hydrus implantation have been published. However, to our knowledge, long-term data over a longer period of time are not yet available. The implementation of this study with a follow-up of the patients after ≥ 8 years (up to 14 years) represents the longest follow-up period to date with a cohort of up to 202 eyes in Mainz, Germany. It enables the collection of "real world data" ≥ 8 years after the Hydrus implantation and provides information about the current status of glaucoma and the effect of the Hydrus implant over this long period (including IOP status, IOP-lowering interventions that have taken place in the meantime, the status of the IOP-lowering medications used, ocular safety, quality of life etc.).

Primary outcome measures

• • Mean non washed out IOP (mmHg) reduction after 8 years of follow-up in glaucoma patients undergoing concomitant implantation of the Hydrus implant and phacoemulsification [Time frame: 8 years]

Secondary outcome measures (4)

• Effect of IOP lowering medications in those Glaucoma patients whom underwent combined Hydrus stent implantation and Phacoemulsification. [Time frame: 8 years]
• Rate of Progression of Mean defect in visual field examination in Glaucoma patients undergoing concomitant implantation of the Hydrus implant and phacoemulsification [Time frame: 8 years]
• Numbers of IOP lowering secondary surgical interventions during 8 years of follow-up in glaucoma patients undergoing concomitant implantation of the Hydrus implant and phacoemulsification. [Time frame: 8 years]
• Differentiation of IOP reduction and safety between eyes of the patients after 8-years of follow-up (in subjects who received the Hydrus implant in both eyes) [Time frame: 8 years]

Eligibility criteria

Inclusion criteria

1\. Patient participated in one of the following trials in the clinical trial site in Mainz:

• the Ivantis, Inc. HYDRUS I trial (NCT03065036),
• the Ivantis, Inc. HYDRUS II trial (NCT01818115),
• the Ivantis, Inc. HYDRUS IV trial (NCT01539239),
• or in the retrospective SPECTRUM data collection. 2. Patient received either concomitant implantation of the Hydrus implant and phacoemulsification or the Hydrus implant alone or participated in the control group (phacoemusification alone) 3. Patient has a minimum follow-up period after surgery of 8 years at the study visit 4. Willingness to participate in the study, the subject's signed and dated informed consent must be submitted before the start of the study 5. Ability of subject to give consent

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Exclusion criteria

1\. Simultaneous participation in another interventional study or past interventions whose effect may still be ongoing (30 days)

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Germany · 1 center

• Department of Opthalmology — Mainz

Identifiers

NCT: NCT07460791 · 24-02116 · IIT#94592191

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗