GlaucomaTAPMP3NCT04448080
Comparison of Topical Anesthesia and Analgosedation in Micropulse Transscleral Glaucoma Treatment
A study testing Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT) in people with Glaucoma, run by University of Zurich at 1 site in Switzerland.
Trial summary
Topical Anesthesia will be compared to Analgosedation for pain control in Micropulse Transscleral Laser Treatment for Glaucoma (MP-TLT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Ophthalmology
Zurich, Canton of Zurich, 8091
About this study
Official title: 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).
Read the 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.
- Conditions
- Glaucoma
- Being tested
- Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT)
- Keywords
- Glaucoma, Micropulse Transscleral Treatment for Glaucoma, Pain
- Medical subject headings
- Glaucoma, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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.)
Measured: 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.)
Measured: 1 day postop
Secondary outcomes (6)
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.)
Measured: 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.)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: at 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start1 Jun 2020
- Primary completion30 Nov 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Töteberg-Harms, MD, FEBO, Principal investigator, University Hospital Zurich, Dpt. of Ophthalmology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448080
- Sponsor's protocol ID
- TAP MP3
- Acronym
- TAPMP3
- Status last verified
- Jun 2023
- First submitted
- 8 Jun 2020
- Last updated
- 2 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Anesthesia vs. Analgosedation and Pain in Micropulse Transscleral Glaucoma Treatment
- ClinicalTrials.gov ID
- NCT04448080
- Acronym / sponsor ID
- TAPMP3 / TAP MP3
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Micropulse Transscleral Treatment for Glaucoma, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomised, non-blinded, controlled clinical study comparing two types of anesthesia for MicroPulse Transscleral Laser Treatment for Glaucoma
| Arm | Type | Receives |
|---|---|---|
| Topical Anesthesia | Experimental | Device: Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT)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 |
| Analgosedation | Active comparator | Device: Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT)Remifentanil 1mg i.v., and, Thiopental i.v., adapted to patients' weight, age, and hepatic and renal function; usually, a bolus of 150-250mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Device | Analgosedation, Topical Anesthesia |
Primary outcome
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.)
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.)
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.)
6 secondary outcomes
Pain at 1 week postop
Time frame: 1 week postop
Pain at 1 month postop
Time frame: 1 month postop
Change in Goldman-applanation intraocular pressure
Time frame: at 1 month
Change in number of hypotensive medication
Time frame: at 1 month
Change in best corrected decimal Snellen visual acuity
Time frame: at 1 month
visual related quality of life
Time frame: at 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Töteberg-Harms, MD, FEBO principal investigator
University Hospital Zurich, Dpt. of Ophthalmology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT) in people with Glaucoma, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain at 1 hour postop (time frame: 1 hour postop). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2023.