24-hour IOP Fluctuation Profile Recorded With SENSIMED Triggerfish in Primary Open-angle Glaucoma (POAG) Patients After Cataract Surgery
| Status: | Completed |
|---|---|
| Conditions: | Ocular |
| Therapuetic Areas: | Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 4/2/2016 |
| Start Date: | December 2011 |
| End Date: | October 2012 |
| Contact: | Felipe Medeiros, MD |
| Email: | fmedeiros@glaucoma.ucsd.edu |
The purpose of this study is to determine the relationship between intraocular pressure
(IOP) fluctuations of glaucoma patients as recorded with an IOP-sensing contact lens
(SENSIMED Triggerfish®), during two 24-hour periods, before and after cataract surgery. This
device has previously been investigated and shown to be safe and well tolerated.
(IOP) fluctuations of glaucoma patients as recorded with an IOP-sensing contact lens
(SENSIMED Triggerfish®), during two 24-hour periods, before and after cataract surgery. This
device has previously been investigated and shown to be safe and well tolerated.
Inclusion Criteria:
- Subject is able to comply with the study procedures
- 18-80 years old
- Subjects diagnosed with glaucoma, based on presence of repeatable visual field
loss and/or glaucomatous optic neuropathy based on masked review of optic disc
stereophotographs and under ocular hypotensive treatment, or diagnosed with
ocular hypertension, with an IOP of > 22 mmHg at the screening visit and under
ocular hypotensive treatment.
- Subject has consented to be in the trial
- Visual acuity of 20/200 or better
- Presence of cataract requiring phacoemulsification with lens exchange
- Ability to understand the character and individual consequences of the study
- For women of childbearing potential, adequate contraception
Exclusion Criteria:
- Subjects presenting with any of the following criteria will not be included in the
trial:
- Subjects with contraindications for wearing contact lenses
- Severe dry eye syndrome
- Keratoconus or other corneal abnormality
- Conjunctival or intraocular inflammation
- Eye surgery prior to and throughout the study.
- Full frame metal glasses during SENSIMED Triggerfish® monitoring
- Known hypersensitivity to silicone, plaster or ocular anesthesia (proparacaine)
- Pregnancy and lactation
- Simultaneous participation in other clinical studies
We found this trial at
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