Comparison of Topical Anesthesia and Analgosedation in Micropulse Transscleral Glaucoma Treatment

Glaucoma Clinical Trial

— TAPMP3  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04448080
• Other study ID #: TAP MP3
• Status: Completed
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2023
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: December 31, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

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

Locations

Country	Name	City	State
Switzerland	Department of Ophthalmology	Zurich	ZH

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	pupil diameter	change in pupil diameter at 1 month compared to baseline will be assessed	at 1 month
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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