Trial Outcomes & Findings for Glaucoma Surgery Using the ViaLase Laser System (NCT NCT04949802)

NCT ID: NCT04949802

Last Updated: 2023-10-17

Results Overview

continuous, mean IOP

Recruitment status

COMPLETED

Study phase

Target enrollment

22 participants

Primary outcome timeframe

12 months

Results posted on

2023-10-17

Participant Flow

Unit of analysis: eyes

Participant milestones

Participant milestones
Measure	Laser Treated with ViaLase Laser ViaLase Laser System to create an aperture through the trabecular meshwork for the reduction of IOP in subjects with primary open-angle glaucoma
Overall Study STARTED	15 22
Overall Study COMPLETED	12 18
Overall Study NOT COMPLETED	3 4

Reasons for withdrawal

Reasons for withdrawal
Measure	Laser Treated with ViaLase Laser ViaLase Laser System to create an aperture through the trabecular meshwork for the reduction of IOP in subjects with primary open-angle glaucoma
Overall Study Lost to Follow-up	3

Baseline Characteristics

Glaucoma Surgery Using the ViaLase Laser System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Laser n=22 eyes treated with Vialase Laser
Age, Continuous	69.5 years STANDARD_DEVIATION 11.1 • n=99 Participants
Sex: Female, Male Female	13 Participants n=99 Participants
Sex: Female, Male Male	2 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	0 Participants n=99 Participants
Race (NIH/OMB) White	15 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment Hungary	15 participants n=99 Participants
IOP	21.3 mmHg STANDARD_DEVIATION 4.2 • n=32 eyes

PRIMARY outcome

Timeframe: 12 months

Population: PP

continuous, mean IOP

Outcome measures

Outcome measures
Measure	Laser n=18 eyes treated with ViaLase Laser ViaLase Laser System to create an aperture through the trabecular meshwork for the reduction of IOP in subjects with primary open-angle glaucoma
Mean IOP	12.7 mmHg Standard Deviation 2.3

PRIMARY outcome

Timeframe: 12 months

Population: PP

Mean Percent Change From Baseline in Intraocular Pressure

Outcome measures

Outcome measures
Measure	Laser n=18 eyes treated with ViaLase Laser ViaLase Laser System to create an aperture through the trabecular meshwork for the reduction of IOP in subjects with primary open-angle glaucoma
Percent Change From Baseline in Intraocular Pressure	-38.5 percentage change from baseline Standard Deviation 9.8

SECONDARY outcome

Timeframe: 12 months

Population: PP

binary, number of eyes that had an IOP reduction of at least 20% from baseline

Outcome measures

Outcome measures
Measure	Laser n=18 eyes treated with ViaLase Laser ViaLase Laser System to create an aperture through the trabecular meshwork for the reduction of IOP in subjects with primary open-angle glaucoma
Number of Eyes That Achieved >=20% IOP Reduction	18 eyes

Adverse Events

Laser

Serious events: 3 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Laser n=15 participants at risk Treated with ViaLase Laser ViaLase Laser System to create an aperture through the trabecular meshwork for the reduction of IOP in subjects with primary open-angle glaucoma
Infections and infestations COVID 19	20.0% 3/15 • Number of events 3 • 12 months

Other adverse events

Other adverse events
Measure	Laser n=15 participants at risk Treated with ViaLase Laser ViaLase Laser System to create an aperture through the trabecular meshwork for the reduction of IOP in subjects with primary open-angle glaucoma
Eye disorders Cystoid Macular Edema	6.7% 1/15 • Number of events 1 • 12 months
Eye disorders Anterior Ischemic Optic Neuropathy	6.7% 1/15 • Number of events 1 • 12 months
Eye disorders BCVA loss >= 2 lines	13.3% 2/15 • Number of events 2 • 12 months
Eye disorders Visual Field progression, MD loss >=2.5dB	6.7% 1/15 • Number of events 1 • 12 months

Additional Information

Melvin Sarayba, MD

ViaLase Inc.

Phone: 9494662856

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place