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This clinical trial is a prospective, randomized, controlled, multicenter, study. After informed consent is obtained, patients will be evaluated for eligibility based on glaucoma severity, eye health, and visual acuity. Following successful screening, use of all topical glaucoma medications will be stopped for a period of "washout" to establish a qualifying medication-free intraocular pressure (IOP) value. Clinical follow up will be scheduled over the course of the 24 month study, and examinations will be repeated to monitor eye health. At the 1 and 2 year follow up, those patients on ocular hypotensive medications will be instructed to washout, and then have the diurnal (IOP taken in the morning, mid-day, and afternoon in the same day) IOP evaluation. Annual follow up will occur up to 5 years. The primary effectiveness endpoint is a decrease in diurnal IOP from baseline compared to the 24 months diurnal IOP following medication washout.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydrus Aqueous Implant (Treatment) | Experimental | Cataract surgery plus Hydrus Aqueous Implant |
|
| Cataract Surgery (Control) | Active Comparator | Cataract surgery only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydrus Aqueous Implant | Device | The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout. | Percentage of eyes in which diurnal IOP was reduced by greater than or equal to 20% at 24 months postoperative compared to baseline after washout of topical glaucoma medications. | Baseline and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Diurnal Washed Out IOP Change From Baseline at 24 Months Compared Between Treatment and Control Groups. | Mean diurnal IOP change from baseline at 24 months between both groups after washout of topical glaucoma medications. | Baseline and 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alan Crandall, MD | The Eye institute of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Phoenix | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32143828 | Derived | Zebardast N, Zheng C, Jampel HD. Effect of a Schlemm's Canal Microstent on Early Postoperative Intraocular Pressure after Cataract Surgery: An Analysis of the HORIZON Randomized Controlled Trial. Ophthalmology. 2020 Oct;127(10):1303-1310. doi: 10.1016/j.ophtha.2020.01.025. Epub 2020 Jan 23. | |
| 29945799 | Derived |
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Of the 1,143 enrolled, 572 were screen failures and 15 were excluded intraoperatively due to failure to meet all intraoperative eligibility criteria. At the time of reporting, 556 patients randomized are available for analysis.
Patients were screened and enrolled at 38 investigational sites in the United States and other countries.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hydrus Aqueous Implant (Treatment) | Cataract surgery plus Hydrus Aqueous Implant Hydrus Aqueous Implant: The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2011 |
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| Cataract surgery | Procedure | A monofocal intraocular lens (IOL) placed during the cataract surgery. |
|
| Tucson |
| Arizona |
| United States |
| Fayetteville | Arkansas | United States |
| La Jolla | California | United States |
| Orange | California | United States |
| Sacramento | California | United States |
| Fort Collins | Colorado | United States |
| Parker | Colorado | United States |
| Bradenton | Florida | United States |
| Fort Myers | Florida | United States |
| Ocala | Florida | United States |
| Sioux City | Iowa | United States |
| Garden City | Kansas | United States |
| Louisville | Kentucky | United States |
| Sandwich | Massachusetts | United States |
| Bloomington | Minnesota | United States |
| Chesterfield | Missouri | United States |
| Wilmington | North Carolina | United States |
| Cleveland | Ohio | United States |
| Mason | Ohio | United States |
| Maryville | Tennessee | United States |
| Austin | Texas | United States |
| Dallas | Texas | United States |
| Fort Worth | Texas | United States |
| Salt Lake City | Utah | United States |
| Racine | Wisconsin | United States |
| Edmonton | Alberta | Canada |
| Boisbriand | Quebec | Canada |
| Mainz | Germany |
| Parma | Italy |
| Tijuana | Mexico |
| Manila | Philippines |
| Warsaw | Poland |
| Madrid | Spain |
| Zaragoza | Spain |
| London | United Kingdom |
| Manchester | United Kingdom |
| Norwich | United Kingdom |
| Samuelson TW, Chang DF, Marquis R, Flowers B, Lim KS, Ahmed IIK, Jampel HD, Aung T, Crandall AS, Singh K; HORIZON Investigators. A Schlemm Canal Microstent for Intraocular Pressure Reduction in Primary Open-Angle Glaucoma and Cataract: The HORIZON Study. Ophthalmology. 2019 Jan;126(1):29-37. doi: 10.1016/j.ophtha.2018.05.012. Epub 2018 Jun 23. |
| Cataract Surgery (Control) |
Cataract surgery only Cataract surgery: A monofocal intraocular lens (IOL) placed during the cataract surgery. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Intent-to-Treat (ITT) - All participants randomized and grouped according to their randomization assignment (as randomized). The ITT is used for the analyses of the primary and secondary effectiveness endpoints.
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| ID | Title | Description |
|---|---|---|
| BG000 | Hydrus Aqueous Implant (Treatment) | Cataract surgery plus Hydrus Aqueous Implant Hydrus Aqueous Implant: The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL. |
| BG001 | Cataract Surgery (Control) | Cataract surgery only Cataract surgery: A monofocal intraocular lens (IOL) placed during the cataract surgery. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reduction in Mean Diurnal IOP From Baseline at 24 Months Following Medication Washout. | Percentage of eyes in which diurnal IOP was reduced by greater than or equal to 20% at 24 months postoperative compared to baseline after washout of topical glaucoma medications. | Intent-to-Treat (ITT) | Posted | Number | percentage of eyes | Baseline and 24 months | Eyes | Eyes |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Mean Diurnal Washed Out IOP Change From Baseline at 24 Months Compared Between Treatment and Control Groups. | Mean diurnal IOP change from baseline at 24 months between both groups after washout of topical glaucoma medications. | Intent-to-Treat (ITT) | Posted | Mean | Standard Deviation | mmHg | Baseline and 24 months |
|
|
24 months
An adverse event is any untoward medical occurrence, unintended disease or injury, or untoward clinical signs in subjects, users or other persons, whether or not related to the investigational medical device. All subjects who have been exposed to the study treatment were evaluated for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hydrus Aqueous Implant (Treatment) | Cataract surgery plus Hydrus Aqueous Implant Hydrus Aqueous Implant: The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL. | 5 | 369 | 10 | 369 | 106 | 369 |
| EG001 | Cataract Surgery (Control) | Cataract surgery only Cataract surgery: A monofocal intraocular lens (IOL) placed during the cataract surgery. | 5 | 187 | 6 | 187 | 24 | 187 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| BCVA loss greater than or equal to 2 lines ETDRS greater than or equal to 3 months | Eye disorders | Systematic Assessment |
| ||
| Corneal Edema Mild to Mod after 1 month | Eye disorders | Systematic Assessment |
| ||
| Glaucoma progression | Eye disorders | Systematic Assessment |
| ||
| Neovascular Glaucoma | Eye disorders | Systematic Assessment |
| ||
| Repair of malpositioned IOL haptic | Eye disorders | Systematic Assessment |
| ||
| Orbital hemangioma | Eye disorders | Systematic Assessment |
| ||
| Squamous cell carcinoma of the conjunctiva | Eye disorders | Systematic Assessment |
| ||
| Worsening of visual field MD by greater than or equal to 2.5 dB compared with preoperative | Eye disorders | Systematic Assessment |
| ||
| Retinal Complications | Eye disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anterior uveitis/iritis (non-persistent) | Eye disorders | Systematic Assessment |
| ||
| Conjunctivitis | Eye disorders | Systematic Assessment |
| ||
| Device obstruction, partial or complete | Eye disorders | Systematic Assessment |
| ||
| Peripheral anterior synechiae without device obstruction | Eye disorders | Systematic Assessment |
| ||
| Worsening of visual field MD by greater than or equal to 2.5 dB compared with preoperative | Eye disorders | Systematic Assessment |
|
Sites participating in the trial may not publish their single center results until the aggregate study results have been published unless first obtaining written consent from the sponsor.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Hope | Ivantis | 949-333-1310 | rhope@ivantisinc.com |
| Sep 5, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D005901 | Glaucoma |
| D002386 | Cataract |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D007905 | Lens Diseases |
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| ID | Term |
|---|---|
| D002387 | Cataract Extraction |
| ID | Term |
|---|---|
| D054140 | Refractive Surgical Procedures |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|