Comparison of Topical Anesthesia and Analgosedation in Micropulse Transscleral Glaucoma Treatment
- Conditions
- Glaucoma
- Interventions
- Device: Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT)
- Registration Number
- NCT04448080
- Lead Sponsor
- University of Zurich
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 8
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Topical Anesthesia 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 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
- Primary Outcome Measures
Name Time Method Pain at 1 day postop 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.)
Pain at 1 hour postop 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 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.)
- Secondary Outcome Measures
Name Time Method Change in number of hypotensive medication 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.
Pain at 1 week postop 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 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 at 1 month The change in intraocular pressure (IOP, \[mmHg\]) at one month compared to baseline will be computed.
Change in best corrected decimal Snellen visual acuity at 1 month The change in best corrected decimal Snellen visual acuity at one month compared to baseline will be computed.
visual related quality of life 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).
Trial Locations
- Locations (1)
Department of Ophthalmology
🇨🇭Zurich, ZH, Switzerland