Department of Ophthalmology, Konkuk University Medical Center
Seoul, 05030, South Korea
NCT Number: NCT05159414
This study aims to evaluate the efficacy and safety of applying pulse electrical stimulation around eyes of glaucoma patients.
Looking for future studies?
Notify Me19 year–75 year
All sexes
Interventional
Not applicable
Seoul, 05030, South Korea
Duration of study period(per participant): Screening period(0-4weeks), Intervention period(16weeks) Patient needs to visit site at least 5 times(Screening, V2, V3, V4, V5). V2 can be done with screening visit. Visit 3, 4, 5 is 2weeks, 6weeks, and 16weeks after visit 2(Baseline).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Pulse Electrical Stimulation Patients wear our clinical trial device 30mins once a day for 16weeks.
Time frame: baseline, 2, 6, 12, 16 weeks
Check the change of intraocular pressure in the baseline, 2, 6, 12, 16 weeks
Time frame: baseline, 2, 6, 12, 16 weeks
Check the change of visual acuity in the baseline, 2, 6, 12, 16 weeks
Time frame: baseline, 2, 6, 12, 16 weeks
Check the change of mean deviation(MD) in the baseline, 2, 6, 12, 16 weeks
Time frame: baseline, 2, 6, 12, 16 weeks
Check the change of pattern standard deviation(PSD) in the baseline, 2, 6, 12, 16 weeks
Time frame: baseline, 2, 6, 12, 16 weeks
Check the change of visual field index(VFI) in the baseline, 2, 6, 12, 16 weeks
Time frame: baseline, 6, 16 weeks
Check the change of parapapillary retinal nerve fiber layer thickness(RNFLT) in the baseline, 6, 16 weeks
Time frame: baseline, 6, 16 weeks
Check the change of Laminar cribrosa(LC) depth in the baseline, 6, 16 weeks
Time frame: baseline, 6, 16 weeks
Check the change of macular ganglion cell-inner plexiform layer thickness(GCIPLT) in the baseline, 6, 16 weeks
Time frame: baseline, 6, 16 weeks
Check the change of circumpapillary vessel density(cpVD) in the baseline, 6, 16 weeks
Time frame: baseline, 6, 16 weeks
Check the change of macular vessel density(mVD) in the baseline, 6, 16 weeks
Time frame: baseline, 6, 16 weeks
Check the change of N95 amplitude in the baseline, 6, 16 weeks
Time frame: baseline, 6, 16 weeks
Check the change of latency in the baseline, 6, 16 weeks
Time frame: baseline, 6, 16 weeks
Check the change of Glaucoma Quality of Life-15(GQL-15) score in the baseline, 6, 16 weeks
Nu Eyne Co., Ltd.
Industry
A Single Center, Open-label, Exploratory Study to Evaluate the Efficacy and Safety of the Application of Pulse Electrical Stimulation Around the Eye in Glaucoma Patients
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06960629
Corneal Diseases, Corneal Edema
Zagreb, Croatia
View Trial DetailsNCT07730424
Eye Diseases, Glaucoma
Fitzroy, Victoria, Australia
View Trial DetailsNCT07168902
Eye Diseases, Glaucoma
Glendale, California, United States
View Trial DetailsNCT04132401
Age-Related Macular Degeneration, Cardiovascular Diseases
Manresa, Barcelona, Spain
View Trial Details