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

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

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

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: Micropulse Transscleral Laser Therapy 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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marc Töteberg-Harms, MD, FEBO; Phone Number: +41442558794 +41442558794; Email: marc.toeteberg@usz.ch
• Study Contact Backup: Name: Iwi Krzyzanowska, MD; Phone Number: +41442558794 +41442558794; Email: iwona.krzyzanowska@usz.ch

Study Locations

• Switzerland
  • ZH
    • Zurich, ZH, Switzerland, 8091
      • Department of Ophthalmology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: 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
Active Comparator: 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	Device: 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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
pupil diameter	change in pupil diameter at 1 month compared to baseline will be assessed	at 1 month

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Marc Töteberg-Harms, MD, FEBO, University Hospital Zurich, Dpt. of Ophthalmology

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 25, 2020

Study Record Updates

• Last Update Posted (Actual): June 2, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Glaucoma; Micropulse Transscleral Treatment for Glaucoma
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: TAP MP3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No