Comparison of Topical Anesthesia and Analgosedation in Micropulse Transscleral Glaucoma Treatment (TAPMP3)

University of Zurich (UZH)

Status: Completed

Conditions: Glaucoma

Treatments: Device: Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04448080

TAP MP3

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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8 participants in 2 patient groups

Topical Anesthesia

Experimental group

Description:

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

Treatment:

Device: Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT)

Analgosedation

Active Comparator group

Description:

Remifentanil 1mg i.v., and, Thiopental i.v., adapted to patients' weight, age, and hepatic and renal function; usually, a bolus of 150-250mg

Treatment:

Device: Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT)