Comparison of Topical Anesthesia and Analgosedation in Micropulse Transscleral Glaucoma Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2020-12-31

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).

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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.

Conditions

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a randomised, non-blinded, controlled clinical study comparing two types of anesthesia for MicroPulse Transscleral Laser Treatment for Glaucoma

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

non

Study Groups

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Topical Anesthesia

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

Group Type EXPERIMENTAL

Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT)

Intervention Type DEVICE

Intraocular pressure will be lowered by Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT) in patients with a diagnosis of glaucoma

Analgosedation

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

Group Type ACTIVE_COMPARATOR

Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT)

Intervention Type DEVICE

Intraocular pressure will be lowered by Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT) in patients with a diagnosis of glaucoma

Interventions

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Micropulse 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

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No