Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06607705
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-16
Brief Title:
Changes in Eye Pressure in Glaucoma Patients Treated with Istent Inject W Monitored by a Contact Lens Sensor
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Fluctuations of the Intraocular Pressure in Surgically Treated Glaucoma Patients with IStent Inject W by a Contact Lens Sensor
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare the IOP-related fluctuations using the CLS contact lens sensor Sensimed Triggerfish in glaucoma patients before and after glaucoma surgery with iStent inject W under physiological conditions and compare these results with a control group of glaucoma patients treated only with hypotensive medical treatment requiring cataract surgery
Detailed Description:
This is a prospective controlled pre-post intervention study conducted at a Hospital Clínic of Barcelona a university hospital in Barcelona Spain This study will be adhered to the tenets of the Declaration of Helsinki Informed patient consent and approval by the Institutional Review Board will be obtained prior to study commencement Study duration is expected to be around 12 months recruitment period would last between 6 to 8 months and study is expected to be finalized by Jun 2025
The study will recruit consenting adults over 18 years old with unilateral or bilateral primary open-angle glaucoma POAG without previous eye surgery treated with topical anti-glaucoma medications who need glaucoma surgery with iStent inject W The investigators will include patients with isolate iStent surgery and patients with combined cataract and iStent surgery In cases of bilateral glaucoma the two eyes of the same patient may be included consecutively
One month prior to glaucoma surgery with iStent inject W subjects will wear the CLS for 24 hours without changing the regimen of anti-glaucoma eye drops The CLS will be placed on the subjects eye by an ophthalmologist in the clinic after a slit lamp examination and keratometry to determine the corneal curvature for selection of the appropriate CLS base curve The subjects will then return home and carry on their routine activities both indoor and outdoor apart from showering or swimming as the device cannot be in contact with water Subjects will continue the same regimen of anti-glaucoma eye drops and slept in their habitual position at night Each subject will carry a logbook to record sleeping and medication instillation times during the 24-hour period After 24 hours the subject will return to the clinic to have the contact lens removed followed by a slit lamp examination The data recorded by the CLS will be uploaded into a computer database Goldmann applanation tonometry GAT will be perform before and after each CLS wear by a single observer At 1-month n944 and 3-month n44 post-glaucoma surgery with iStent implant patients will wear the CLS in the same eye that received the first CLS recording As before the CLS will be removed 24 hours later To extend the follow-up to 3 months after surgery will allow us to corroborate that the effects of the surgery on fluctuations of IOP for 24 hours are maintained over time In the control group n10 a first monitoring with CLS will be carried out one month before cataract surgery and a second monitoring will be carried out 3 months after this cataract surgery without us having introduced any changes in their hypotensive medical treatment
The study will recruit consenting adults over 18 years old with unilateral or bilateral primary open-angle glaucoma POAG without previous eye surgery treated with topical anti-glaucoma medications who need glaucoma surgery with iStent inject W The investigators will include patients with isolate iStent surgery and patients with combined cataract and iStent surgery In cases of bilateral glaucoma the two eyes of the same patient may be included consecutively
One month prior to glaucoma surgery with iStent inject W subjects will wear the CLS for 24 hours without changing the regimen of anti-glaucoma eye drops The CLS will be placed on the subjects eye by an ophthalmologist in the clinic after a slit lamp examination and keratometry to determine the corneal curvature for selection of the appropriate CLS base curve The subjects will then return home and carry on their routine activities both indoor and outdoor apart from showering or swimming as the device cannot be in contact with water Subjects will continue the same regimen of anti-glaucoma eye drops and slept in their habitual position at night Each subject will carry a logbook to record sleeping and medication instillation times during the 24-hour period After 24 hours the subject will return to the clinic to have the contact lens removed followed by a slit lamp examination The data recorded by the CLS will be uploaded into a computer database Goldmann applanation tonometry GAT will be perform before and after each CLS wear by a single observer At 1-month n944 and 3-month n44 post-glaucoma surgery with iStent implant patients will wear the CLS in the same eye that received the first CLS recording As before the CLS will be removed 24 hours later To extend the follow-up to 3 months after surgery will allow us to corroborate that the effects of the surgery on fluctuations of IOP for 24 hours are maintained over time In the control group n10 a first monitoring with CLS will be carried out one month before cataract surgery and a second monitoring will be carried out 3 months after this cataract surgery without us having introduced any changes in their hypotensive medical treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None