Comparison of Topical Anesthesia and Analgosedation in Micropulse Transscleral Glaucoma Treatment

NCT04448080 | Completed

• 1 other identifier: TAP MP3
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glaucoma

Keywords

Glaucoma; Micropulse Transscleral Treatment for Glaucoma; Pain

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Pain at 1 week postop

  1 week postop

• Pain at 1 month postop

  1 month postop

• Change in Goldman-applanation intraocular pressure

  at 1 month

• Change in number of hypotensive medication

  at 1 month

• Change in best corrected decimal Snellen visual acuity

  at 1 month

Other Outcomes (1)

• pupil diameter

  at 1 month

Study Arms (2)

Topical Anesthesia

EXPERIMENTAL

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)

Analgosedation

ACTIVE COMPARATOR

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)

Interventions

Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT) DEVICE

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

Analgosedation; Topical Anesthesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Department of Ophthalmology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Glaucoma; Pain

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Marc Töteberg-Harms, MD, FEBO

  University Hospital Zurich, Dpt. of Ophthalmology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: non
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 25, 2020
• Study Start: June 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2020
• Last Updated: June 2, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)