Clinical trial NCT04448080: Comparison of Topical Anesthesia and Analgosedation in Micropulse Transscleral Glaucoma Treatment
Official title: Topical Anesthesia vs. Analgosedation and Pain in Micropulse Transscleral Glaucoma Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Glaucoma
Micropulse Transscleral Treatment for Glaucoma
Pain
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomised, non-blinded, controlled clinical study comparing two types of anesthesia for MicroPulse Transscleral Laser Treatment for Glaucoma
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain at 1 hour postop
timeFrame: 1 hour postop
measure: Pain at 6 hours postop
timeFrame: 6 hours postop
measure: Pain at 1 day postop
timeFrame: 1 day postop
Secondary outcomes:
measure: Pain at 1 week postop
timeFrame: 1 week postop
measure: Pain at 1 month postop
timeFrame: 1 month postop
measure: Change in Goldman-applanation intraocular pressure
timeFrame: at 1 month
measure: Change in number of hypotensive medication
timeFrame: at 1 month
measure: Change in best corrected decimal Snellen visual acuity
timeFrame: at 1 month
measure: visual related quality of life
timeFrame: at 1 month
Other outcomes:
measure: pupil diameter
timeFrame: at 1 month
Locations:
city: Zurich
country: Switzerland
facility: Department of Ophthalmology
state: ZH
Study officials:
affiliation: University Hospital Zurich, Dpt. of Ophthalmology
name: Marc Töteberg-Harms, MD, FEBO
role: PRINCIPAL_INVESTIGATOR
References: