Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04433702
Other study ID # CP-014
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 1, 2020
Est. completion date December 2020

Study information

Verified date May 2024
Source Vance Thompson Vision
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Glaucoma is a leading cause of blindness worldwide. Intraocular pressure (IOP) remains the only modifiable risk factor for glaucoma. Without sufficient IOP lowering therapy, glaucoma induces retinal ganglion cell death and visual field loss. Pattern electroretinography (pERG) measurements directly correlate with retinal ganglion cell (RGC) signaling, providing an objective, repeatable, and non-invasive assessment of RGC function. The purpose of the study is to investigate the pERG changes associated with acute IOP reduction using the Mercury™ Multi-Pressure Dial (MPD). 10 patients will be enrolled. These subjects will have a best corrected visual acuity of 20/40 or better in both eyes and an established diagnosis of one of either mild/moderate OAG (open-angle glaucoma), OHT (ocular hypertension), or glaucoma suspect. Both eyes will be enrolled in the study. The study eye will receive a standardized 10 mmHg decrease in periorbital pressure via the Mercury™ Multi-Pressure Dial (MPD), and the fellow/control eye will receive no (zero) pressure application. Total google wear time will be 4.5 hours. Serial pERG measurements will be taken before, immediately after, and 2 hours after negative pressure application.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date December 2020
Est. primary completion date December 2020
Accepts healthy volunteers No
Gender All
Age group 22 Years and older
Eligibility Inclusion Criteria: - Subjects capable of committing to the duration of the study and signing the informed consent. - Subjects must be male or female and = 22 years of age at the time of signing the informed consent. - Subjects with orbital anatomy that permits a proper seal when goggles are placed over eyes. - Subjects can tolerate ERG measurements. - Subjects with a documented BCVA OU 20/40 or better AND a diagnosis of OHT, glaucoma suspect, or OAG in both eyes. OAG definition is inclusive of normal tension glaucoma, pseudoexfoliation glaucoma, and pigment dispersion. Both eyes require same diagnosis. - Subjects with prior surgeries such as refractive surgeries (e.g., LASIK, PRK, SMILE), cataract surgery, cataract surgery with minimally invasive glaucoma surgery (MIGS), MIGS alone, trabeculectomy, or implantation of other glaucoma drainage devices can be included in the study; however, no other prior ocular surgeries are permitted. - Subjects without lenticular opacities and/or trace (i.e. 1+) lenticular opacities. Exclusion Criteria: - Subjects with a history of allergy to primary study device material (i.e. silicone, anti-fog solution). - Subjects with a history of any ocular disorder or condition in either eye that would likely interfere with the interpretation of the study results or subject safety (e.g., corneal transplant). - Subjects with a history of any demyelinating disorder or condition that would likely interfere with the interpretation of the study results or subject safety (e.g. MS). - Subjects with an untreated retinal detachment, retinal tears, macular degeneration, or any other fundus findings that may prevent accurate ERG measurements in either eye. - Subjects with conjunctival chemosis in either eye. - Subjects with eyelid edema. - Subjects with a history of seizure disorder. - Subjects with an eye infection. - Subjects with moderate-severe (i.e. 2+, 3+, or 4+) lenticular opacities.

Study Design


Intervention

Device:
Mercury™ Multi-Pressure Dial (MPD) Experimental Goggle
The Mercury™ MPD applies negative pressure to one of the two goggles inducing an IOP reduction of 10 mmHg. This is randomized for each subject in the trial. The Mercury™ MPD consists of: Goggles: seal against the bony orbit with straps around head. The goggles separately enclose each eye, with each eye individually connected to a pressure-modulating pump. Programmable pump: applies negative pressure inside the goggles via clear tubing attached to a handheld device
Mercury™ Multi-Pressure Dial (MPD) Placebo Goggle
The Mercury™ MPD applies no negative pressure to one of the two goggles eliciting no IOP reduction. This is randomized for each subject in the trial. The Mercury™ MPD consists of: Goggles: seal against the bony orbit with straps around head. The goggles separately enclose each eye, with each eye individually connected to a pressure-modulating pump. Programmable pump: applies negative pressure inside the goggles via clear tubing attached to a handheld device

Locations

Country Name City State
United States Vance Thompson Vision Sioux Falls South Dakota

Sponsors (1)

Lead Sponsor Collaborator
Vance Thompson Vision

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pattern Electroretinography (pERG) Alterations Mercury™ MPD alters IOP in study eyes of subjects per controlled reduction of pressure. pERG changes induced by the Mercury™ MPD will provide insight into changes in retinal ganglion cells after wearing Mercury™ MPD with negative pressure applied anterior to the orbital rim. 0 hours; 4.5 hours; 6.5 hours
See also
  Status Clinical Trial Phase
Recruiting NCT06000865 - Glaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE N/A
Recruiting NCT06278597 - Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device N/A
Active, not recruiting NCT04271709 - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT) N/A
Recruiting NCT03274024 - The Asia Primary Tube Versus Trab (TVT) Study N/A
Completed NCT04552964 - Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma N/A
Recruiting NCT01957267 - Functional and Structural Imaging for Glaucoma
Active, not recruiting NCT04624698 - iStent Inject New Enrollment Post-Approval Study N/A
Completed NCT04020705 - The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma N/A
Completed NCT03150160 - Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma Phase 4
Not yet recruiting NCT05581498 - Glaucoma Exercise as Medicine Study (GEMS). N/A
Recruiting NCT02921568 - Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes N/A
Active, not recruiting NCT02901730 - Clinical Study of LPI With Different Laser Wavelengths N/A
Completed NCT02955849 - A Trial of China Laser and Surgery Study Glaucoma in Rural China Early Phase 1
Recruiting NCT02471105 - Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml Phase 4
Recruiting NCT02554214 - Pilot Clinical Trial on a New Adjustable Glaucoma Drainage Device N/A
Active, not recruiting NCT02390284 - Stop Retinal Ganglion Cell Dysfunction Study Phase 3
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A
Completed NCT02653963 - Triamcinolone for Ahmed Glaucoma Valve N/A
Completed NCT02628223 - 180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma N/A
Completed NCT02520674 - Glaucoma Screening With Smartphone Ophthalmology N/A