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

June 1, 2023 updated by: University of Zurich

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Marc Töteberg-Harms, MD, FEBO
  • Phone Number: +41442558794 +41442558794
  • Email: marc.toeteberg@usz.ch

Study Contact Backup

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain at 1 hour postop
Time Frame: 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
Time Frame: 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
Time Frame: 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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain at 1 week postop
Time Frame: 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
Time Frame: 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
Time Frame: at 1 month
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
Time Frame: at 1 month
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
Time Frame: at 1 month
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
Time Frame: at 1 month
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
pupil diameter
Time Frame: at 1 month
change in pupil diameter at 1 month compared to baseline will be assessed
at 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Zurich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Marc Töteberg-Harms, MD, FEBO, University Hospital Zurich, Dpt. of Ophthalmology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 8, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 2, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 1, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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