Glaucoma
Conditions
Keywords
Glaucoma, Micropulse Transscleral Treatment for Glaucoma, Pain
Brief summary
Topical Anesthesia will be compared to Analgosedation for pain control in Micropulse Transscleral Laser Treatment for Glaucoma (MP-TLT).
Detailed description
For a patient, the perspective of a surgical treatment can mean both, hope, and anxiety. In particular the fear of pain during and after surgery can cause tremendous anxiety. In addition, possible side effects of general anesthesia and sedation should be considered, in particular, in patients with multiple comorbidities. The investigators want to help patients to cope with their anxiety and, in addition, minimize risks of surgical procedures including side effects of anesthesia. With this project, the investigators aim to investigate whether topical anesthesia - often used in ophthalmologic surgical procedures - can sufficiently control pain during and after a glaucoma laser procedure compared to intravenous analgosedation. As primary objective, the effectiveness in pain control of analgosedation and topical anesthesia in MP-TLT will be compared. As secondary objective, the effect of the anesthetic protocol used on postoperative visual related quality of life will be investigated.
Interventions
DEVICEMicropulse Transscleral Laser Therapy for Glaucoma (MP-TLT)
Intraocular pressure will be lowered by Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT) in patients with a diagnosis of glaucoma
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
non
Intervention model description
This is a randomised, non-blinded, controlled clinical study comparing two types of anesthesia for MicroPulse Transscleral Laser Treatment for Glaucoma
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* diagnosis of primary open angle glaucoma (POAG) * age ≥18 years of age * Visual acuity ≥0.6 Decimal-Snellen * IOP ≥21 mmHg * \</=3 anti-glaucoma drug (AGD) classes
Exclusion criteria
* Diagnosis of cystoid macula edema (CME) observed by optical coherence tomography (OCT) * Status post CME * Diagnosis of epiretinal fibroplasia * Status post other operations than uncomplicated cataract interventions * Status post cataract operation less than 3 months ago
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain at 6 hours postop | 6 hours postop | Pain will be assessed by a Numerical Pain Rating Scale (0 to 10, where 0 stands for no pain, 1 to 3 mild pain, 4 to 6 moderate pain and, 7-10 severe pain.) |
| Pain at 1 day postop | 1 day postop | Pain will be assessed by a Numerical Pain Rating Scale (0 to 10, where 0 stands for no pain, 1 to 3 mild pain, 4 to 6 moderate pain and, 7-10 severe pain.) |
| Pain at 1 hour postop | 1 hour postop | Pain will be assessed by a Numerical Pain Rating Scale (0 to 10, where 0 stands for no pain, 1 to 3 mild pain, 4 to 6 moderate pain and, 7-10 severe pain.) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Goldman-applanation intraocular pressure | at 1 month | The change in intraocular pressure (IOP, \[mmHg\]) at one month compared to baseline will be computed. |
| Change in number of hypotensive medication | at 1 month | The change in the number of hypotensive medication(i.e. medication which lower the intraocular pressure) at one month compared to baseline will be computed. |
| visual related quality of life | at 1 month | change in visual related quality of life at 1 month compared to baseline will be assessed by means of National Eye Institute Visual Function Questionnaire. The National Eye Institute Visual Function Questionnaire nas a minimum value of 0 and a maximum value of 100, wheras 100 means no limitions to a normal visual related quality of life (i.e. higher values represent a better outcome). |
| Change in best corrected decimal Snellen visual acuity | at 1 month | The change in best corrected decimal Snellen visual acuity at one month compared to baseline will be computed. |
| Pain at 1 week postop | 1 week postop | Pain will be assessed by a Numerical Pain Rating Scale (0 to 10, where 0 stands for no pain, 1 to 3 mild pain, 4 to 6 moderate pain and, 7-10 severe pain.) |
| Pain at 1 month postop | 1 month postop | Pain will be assessed by a Numerical Pain Rating Scale (0 to 10, where 0 stands for no pain, 1 to 3 mild pain, 4 to 6 moderate pain and, 7-10 severe pain.) |
Other
| Measure | Time frame | Description |
|---|---|---|
| pupil diameter | at 1 month | change in pupil diameter at 1 month compared to baseline will be assessed |
Countries
Switzerland
Outcome results
None listed