Use of the OMNI® Surgical System in Combination With Cataract Extraction in Open Angle Glaucoma
Primary Purpose
Open Angle Glaucoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transluminal viscoelastic delivery and trabeculotomy
Sponsored by
About this trial
This is an interventional treatment trial for Open Angle Glaucoma
Eligibility Criteria
Inclusion Criteria:
- (only one eye of each subject is eligible, and all ocular criteria apply to the study eye):
- Male or female subjects, 22 years or older.
- Visually significant cataract
- Diagnosed with mild to moderate open angle glaucoma (e.g. primary open angle glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma) per AAO/AGS/ICD-10 Glaucoma Stage Definitions.1
- At screening, on 1-3 IOP-lowering medications2 with a medicated IOP ≤25 mmHg OR on zero (0) IOP-lowering medications with an IOP 21-30 mmHg.
- At baseline, unmedicated diurnal IOP 21-30 mmHg and, for subjects who were medicated at screening, IOP at least 3 mmHg higher than screening IOP.
- Scheduled for cataract extraction followed by abinterno transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System.
- Shaffer grade of ≥ III in all four quadrants
- Potential of good best corrected visual acuity post cataract extraction, in the investigator's judgment
- Able and willing to comply with the protocol, including all follow-up visits.
- Understands and signs the informed consent.
Exclusion Criteria:
- (All criteria apply to the study eye; both eyes of a single subject need not be eligible):
Any of the following prior treatments for glaucoma:
- Laser trabeculoplasty ≤3 months prior to baseline
- iStent implanted ≤6 months prior to baseline
- Implanted with Cypass, Xen, Express, glaucoma draining device/valve, or Hydrus Device
- Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, ECP or CPC
- Normal tension glaucoma
- Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
- Severe glaucoma by AAO/AGS/ICD-10 guideline
- Use of oral hypotensive medication treatment for glaucoma
- History of elevated IOP due to steroid response
- In the investigator's judgement, predisposed to significant risk because of washout of ocular hypotensive medications.
- Ocular pathology or medical condition which, in the investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period (e.g., wet AMD, corneal edema, Fuch's dystrophy, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to investigator's office for follow-up visits).
- Participation (≤ 30 days prior to baseline) in an interventional trial which could have a potential effect on the study outcome, as determined by the study investigator.
Sites / Locations
- El Paso Eye SurgeonsRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Viscoeleastic delivery & trabeculotomy
Arm Description
Patients with open angle glaucoma and cataract
Outcomes
Primary Outcome Measures
Change in mean unmedicated diurnal IOP
Reduction in mean unmedicated diurnal IOP from baseline to 12 months
Change in mean number of IOP-lowering medications
Reduction in mean number of IOP-lowering medications from screening to 12 months
Secondary Outcome Measures
Percent of eyes with a ≥20% reduction in unmedicated diurnal IOP at 12 months
Percent of eyes with unmedicated diurnal IOP between 6 and 18 mmHg inclusive at 12 months
Full Information
NCT ID
NCT03861169
First Posted
February 25, 2019
Last Updated
February 28, 2019
Sponsor
Sight Sciences, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03861169
Brief Title
Use of the OMNI® Surgical System in Combination With Cataract Extraction in Open Angle Glaucoma
Official Title
Prospective, Multi-Center, Post-Market Study of Use of the OMNI® Surgical System in Combination With Cataract Extraction in Open Angle Glaucoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2019 (Actual)
Primary Completion Date
August 30, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sight Sciences, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
This study will prospectively assess the clinical effect of ab-interno transluminal viscoelastic delivery and trabeculotomy performed using the OMNI Surgical System in combination with Cataract Extraction on intraocular pressure (IOP) and the use of IOP-lowering medications in patients with mild-moderate open angle glaucoma (OAG).
Detailed Description
This prospective, multicenter, single-arm, post-market clinical study will evaluate the impact of ab-interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical System in conjunction with cataract surgery on IOP and the use of hypotensive medications in patients with mild to moderate open angle glaucoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
220 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Viscoeleastic delivery & trabeculotomy
Arm Type
Experimental
Arm Description
Patients with open angle glaucoma and cataract
Intervention Type
Device
Intervention Name(s)
Transluminal viscoelastic delivery and trabeculotomy
Intervention Description
Ab-interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical System
Primary Outcome Measure Information:
Title
Change in mean unmedicated diurnal IOP
Description
Reduction in mean unmedicated diurnal IOP from baseline to 12 months
Time Frame
12 months
Title
Change in mean number of IOP-lowering medications
Description
Reduction in mean number of IOP-lowering medications from screening to 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Percent of eyes with a ≥20% reduction in unmedicated diurnal IOP at 12 months
Time Frame
12 months
Title
Percent of eyes with unmedicated diurnal IOP between 6 and 18 mmHg inclusive at 12 months
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Safety Endpoint- Adverse events
Description
Rates of ocular adverse events (intraoperative, postoperative)
Time Frame
12 months
Title
Safety Endpoint- best corrected visual acuity
Description
Reduction in best corrected visual acuity (BCVA) from baseline (note: reduction in BCVA due to PCO will not be treated as a safety event)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- (only one eye of each subject is eligible, and all ocular criteria apply to the study eye):
Male or female subjects, 22 years or older.
Visually significant cataract
Diagnosed with mild to moderate open angle glaucoma (e.g. primary open angle glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma) per AAO/AGS/ICD-10 Glaucoma Stage Definitions.1
At screening, on 1-3 IOP-lowering medications2 with a medicated IOP ≤25 mmHg OR on zero (0) IOP-lowering medications with an IOP 21-30 mmHg.
At baseline, unmedicated diurnal IOP 21-30 mmHg and, for subjects who were medicated at screening, IOP at least 3 mmHg higher than screening IOP.
Scheduled for cataract extraction followed by abinterno transluminal viscoelastic delivery and trabeculotomy using the OMNI Surgical System.
Shaffer grade of ≥ III in all four quadrants
Potential of good best corrected visual acuity post cataract extraction, in the investigator's judgment
Able and willing to comply with the protocol, including all follow-up visits.
Understands and signs the informed consent.
Exclusion Criteria:
- (All criteria apply to the study eye; both eyes of a single subject need not be eligible):
Any of the following prior treatments for glaucoma:
Laser trabeculoplasty ≤3 months prior to baseline
iStent implanted ≤6 months prior to baseline
Implanted with Cypass, Xen, Express, glaucoma draining device/valve, or Hydrus Device
Prior canaloplasty, goniotomy, trabeculotomy, trabeculectomy, ECP or CPC
Normal tension glaucoma
Acute angle closure, traumatic, congenital, malignant, uveitic or neovascular glaucoma
Severe glaucoma by AAO/AGS/ICD-10 guideline
Use of oral hypotensive medication treatment for glaucoma
History of elevated IOP due to steroid response
In the investigator's judgement, predisposed to significant risk because of washout of ocular hypotensive medications.
Ocular pathology or medical condition which, in the investigator's judgment, would either place the subject at increased risk of complications, contraindicate surgery, place the subject at risk of significant vision loss during the study period (e.g., wet AMD, corneal edema, Fuch's dystrophy, etc.), or interfere with compliance to elements of the study protocol (e.g., returning to investigator's office for follow-up visits).
Participation (≤ 30 days prior to baseline) in an interventional trial which could have a potential effect on the study outcome, as determined by the study investigator.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kavita p Dhamdhere, MD, PhD
Phone
16502234062
Email
kdhamdhere@sightsciences.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anne Ripley
Phone
6616458546
Email
Anne@sightsciences.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
kavita p dhamdhere, MD, PhD
Organizational Affiliation
Sight Sciences
Official's Role
Study Director
Facility Information:
Facility Name
El Paso Eye Surgeons
City
El Paso
State/Province
Texas
ZIP/Postal Code
79902
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Gallardo, MD
Phone
915-542-0279
Email
gallardomark@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of the OMNI® Surgical System in Combination With Cataract Extraction in Open Angle Glaucoma
We'll reach out to this number within 24 hrs