Comparison of Topical Anesthesia and Analgosedation in Micropulse Transscleral Glaucoma Treatment (TAPMP3)
Primary Purpose
Glaucoma
Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT)
Sponsored by

About this trial
This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma, Micropulse Transscleral Treatment for Glaucoma, Pain
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
Sites / Locations
- Department of Ophthalmology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Topical Anesthesia
Analgosedation
Arm Description
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
Remifentanil 1mg i.v., and, Thiopental i.v., adapted to patients' weight, age, and hepatic and renal function; usually, a bolus of 150-250mg
Outcomes
Primary Outcome Measures
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.)
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.)
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.)
Secondary Outcome Measures
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.)
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.)
Change in Goldman-applanation intraocular pressure
The change in intraocular pressure (IOP, [mmHg]) at one month compared to baseline will be computed.
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.
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04448080
Brief Title
Comparison of Topical Anesthesia and Analgosedation in Micropulse Transscleral Glaucoma Treatment
Acronym
TAPMP3
Official Title
Topical Anesthesia vs. Analgosedation and Pain in Micropulse Transscleral Glaucoma Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
Glaucoma, Micropulse Transscleral Treatment for Glaucoma, Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomised, non-blinded, controlled clinical study comparing two types of anesthesia for MicroPulse Transscleral Laser Treatment for Glaucoma
Masking
None (Open Label)
Masking Description
non
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Topical Anesthesia
Arm Type
Experimental
Arm Description
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
Arm Title
Analgosedation
Arm Type
Active Comparator
Arm Description
Remifentanil 1mg i.v., and, Thiopental i.v., adapted to patients' weight, age, and hepatic and renal function; usually, a bolus of 150-250mg
Intervention Type
Device
Intervention Name(s)
Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT)
Intervention Description
Intraocular pressure will be lowered by Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT) in patients with a diagnosis of glaucoma
Primary Outcome Measure Information:
Title
Pain at 1 hour postop
Description
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.)
Time Frame
1 hour postop
Title
Pain at 6 hours postop
Description
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.)
Time Frame
6 hours postop
Title
Pain at 1 day postop
Description
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.)
Time Frame
1 day postop
Secondary Outcome Measure Information:
Title
Pain at 1 week postop
Description
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.)
Time Frame
1 week postop
Title
Pain at 1 month postop
Description
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.)
Time Frame
1 month postop
Title
Change in Goldman-applanation intraocular pressure
Description
The change in intraocular pressure (IOP, [mmHg]) at one month compared to baseline will be computed.
Time Frame
at 1 month
Title
Change in number of hypotensive medication
Description
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.
Time Frame
at 1 month
Title
Change in best corrected decimal Snellen visual acuity
Description
The change in best corrected decimal Snellen visual acuity at one month compared to baseline will be computed.
Time Frame
at 1 month
Title
visual related quality of life
Description
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).
Time Frame
at 1 month
Other Pre-specified Outcome Measures:
Title
pupil diameter
Description
change in pupil diameter at 1 month compared to baseline will be assessed
Time Frame
at 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc Töteberg-Harms, MD, FEBO
Organizational Affiliation
University Hospital Zurich, Dpt. of Ophthalmology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology
City
Zurich
State/Province
ZH
ZIP/Postal Code
8091
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Topical Anesthesia and Analgosedation in Micropulse Transscleral Glaucoma Treatment
We'll reach out to this number within 24 hrs