Comparison of Topical Anesthesia and Analgosedation in Micropulse Transscleral Glaucoma Treatment

Study Overview
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Brief Summary
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Topical Anesthesia will be compared to Analgosedation for pain control in Micropulse Transscleral Laser Treatment for Glaucoma (MP-TLT).

Detailed Description
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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.

Official Title
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Topical Anesthesia vs. Analgosedation and Pain in Micropulse Transscleral Glaucoma Treatment

Conditions
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Glaucoma

Intervention / Treatment
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* Device: Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomised, non-blinded, controlled clinical study comparing two types of anesthesia for MicroPulse Transscleral Laser Treatment for Glaucoma
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Topical Anesthesia<br>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 | Device: Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT)<br>* Intraocular pressure will be lowered by Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT) in patients with a diagnosis of glaucoma<br>|
| Active Comparator: Analgosedation<br>Remifentanil 1mg i.v., and, Thiopental i.v., adapted to patients' weight, age, and hepatic and renal function; usually, a bolus of 150-250mg | Device: Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT)<br>* Intraocular pressure will be lowered by Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT) in patients with a diagnosis of glaucoma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Glaucoma, Micropulse Transscleral Treatment for Glaucoma, Pain