Glaucoma
Conditions
Brief summary
A 24 hour profile is recorded using Sensimed Triggerfish in glaucoma patients before and after Trabecuelctomy
Interventions
DEVICEPlacement of Sensimed Triggerfish
Sensimed Triggerfish is placed on the corneal surface
Sponsors
Johannes Gutenberg University Mainz
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient must have the willingness and ability to provide signed informed consent * Patient is able to comply with the study procedure * Patient must be ≥ 18 years old * Diagnosis of primary open angle glaucoma (EGS criteria) including pseudoexfoliation glaucoma/ normal tension glaucoma/ pigmentary glaucoma in the study eye * planned trabeculectomy in the study eye * in preparation for trabeculectomy, all preoperative IOP lowering medication has been replaced by Dorzolamid 20 mg/ml + Timolol 5mg/ml preservative free eye drops in the study eye for at least 28 days before Triggerfish® profile * Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out * Visual Acuity of 20/200 or better in both eyes * Ability of subject to understand the character and individual consequences of the study
Exclusion criteria
* Subjects with contraindications for wearing contact lenses in the study eye * secondary glaucoma in the study eye * History of refractive surgery in the study eye * History of intraocular surgery in the last three months in the study eye * Severe dry eye syndrome as judged by the investigator in the study eye * Keratoconus or other corneal abnormalities * Any other abnormality in the study eye, that prevents the safe placement of the device after investigators decision * Conjunctival or intraocular inflammation in the study eye * Simultaneous participation in other clinical trials * Previous IOP-lowering intervention in the study eye * Current shift workers (applicable for at least 3 months) * Transmeridian flight \< 2 months before screening (6 hours time shift) * Subjects with pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Amplitude | up to 14 weeks | Comparison of Amplitude between the preoperative Triggerfish Profile and the Triggerfish Profile three months after Trabeculectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of other parameters | up to 14 weeks | Correlation of IOP and Triggerfish Profile, Correlation of IOP, blood pressure and heart rate, Evaluation of 24 hours nyctohemeral rhythm of measurements before and after trabeculectomy |
Countries
Germany
Outcome results
None listed