Monitoring of the IOP After SLT Using iCare Home
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|ClinicalTrials.gov Identifier: NCT03310788|
Recruitment Status : Recruiting
First Posted : October 16, 2017
Last Update Posted : October 16, 2017
|Condition or disease|
|Glaucoma Open-Angle Primary Pseudo Exfoliation Syndrome|
Sixty glaucoma patients (POAG and PEX) planned for SLT will be recruited.
At baseline, patients will be trained to use the iCare Home tonometer, a handheld device based on rebound tonometry and designed for patients to use at home. After the training session and when patients feel confident, a measurement will be recorded. Thereafter, a new measurement will be obtained by the study staff (an optometrist or a nurse) using the same device. No IOP values will be visible for the examiner at that point. Thereafter, a single IOP measurement will be obtained by the same study staff using Goldmann applanation tonometry (GAT). Patients will then borrow the iCare Home tonometer to meaure their IOP at 06 and 10 am, and at 2, 6 and 10 pm during three consecutive days to obtain an IOP curve. Patients will come for a second visit where new measurements will be made in the same way as at baseline.
Two months after SLT, a new IOP curve will be obtained following the same procedure as pre-operatively. Patients' daily activities (diet, motion or sleeping habits) will not be controlled.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Monitoring of the Intraocular Pressure After Selective Laser Trabeculoplasty Using iCare Home|
|Actual Study Start Date :||October 3, 2017|
|Estimated Primary Completion Date :||December 20, 2018|
|Estimated Study Completion Date :||December 20, 2019|
- Lowering of IOP fluctuations after SLT [ Time Frame: 2 months ]The amplitude of the IOP fluctuations pre- and post SLT will be compared
- Lowering of IOP level after SLT [ Time Frame: 2 months ]Mean IOP pre- and post SLT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03310788
|Contact: Enping Chen, MD PhDfirstname.lastname@example.org|
|Contact: Laurence Quérat, M Scemail@example.com|
|St Erik Eye Hospital||Recruiting|
|Stockholm, Sweden, 11282|
|Contact: Enping Chen, MD PhD 004686720000 firstname.lastname@example.org|
|Contact: Laurence Quérat, M Sc 004686723240 email@example.com|
|Principal Investigator:||Enping Chen, MD Ph D||St. Erik Eye Hospital|