Status:
WITHDRAWN
Effect of Negative Pressure on Pattern Electroretinography Readings
Lead Sponsor:
Vance Thompson Vision
Conditions:
Glaucoma
Open Angle, Low Risk
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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 g...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04433702
Start Date
October 1 2020
End Date
December 1 2020
Last Update
May 20 2024
Active Locations (1)
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1
Vance Thompson Vision
Sioux Falls, South Dakota, United States, 57108