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Topical Anesthesia will be compared to Analgosedation for pain control in Micropulse Transscleral Laser Treatment for Glaucoma (MP-TLT).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topical Anesthesia | Experimental | topical tetracaine eye drops (3 times, given in 1 minute intervals) followed by topical Xylocaine 2% Gel (alcohol-free formulation), given in 1 minute intervals for a total of 5 minutes |
|
| Analgosedation | Active Comparator | Remifentanil 1mg i.v., and, Thiopental i.v., adapted to patients' weight, age, and hepatic and renal function; usually, a bolus of 150-250mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT) | Device | Intraocular pressure will be lowered by Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT) in patients with a diagnosis of glaucoma |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at 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.) | 1 hour postop |
| Pain at 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.) | 6 hours postop |
| Pain at 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.) | 1 day postop |
| Measure | Description | Time Frame |
|---|---|---|
| Pain at 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.) | 1 week postop |
| Pain at 1 month postop |
| Measure | Description | Time Frame |
|---|---|---|
| pupil diameter | change in pupil diameter at 1 month compared to baseline will be assessed | at 1 month |
Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Töteberg-Harms, MD, FEBO | University Hospital Zurich, Dpt. of Ophthalmology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Ophthalmology | Zurich | Canton of Zurich | 8091 | Switzerland |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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This is a randomised, non-blinded, controlled clinical study comparing two types of anesthesia for MicroPulse Transscleral Laser Treatment for Glaucoma
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non
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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.)
| 1 month postop |
| Change in Goldman-applanation intraocular pressure | The change in intraocular pressure (IOP, [mmHg]) at one month compared to baseline will be computed. | at 1 month |
| Change in number of hypotensive medication | 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. | at 1 month |
| Change in best corrected decimal Snellen visual acuity | The change in best corrected decimal Snellen visual acuity at one month compared to baseline will be computed. | at 1 month |
| visual related quality of life | 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). | at 1 month |
| D013568 |
| Pathological Conditions, Signs and Symptoms |