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NCT Number: NCT04448080

Comparison of Topical Anesthesia and Analgosedation in Micropulse Transscleral Glaucoma Treatment

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

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Key information

Conditions

Glaucoma Eye Diseases Neurologic Manifestations Ocular Hypertension Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Ophthalmology

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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.)

  2. 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.)

  3. 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.)

Secondary outcomes

  1. 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.)

  2. 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.)

  3. 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.

  4. 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.

  5. 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.

  6. 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).

Other outcomes

  1. pupil diameter

    Time frame: at 1 month

    change in pupil diameter at 1 month compared to baseline will be assessed

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Acronym: TAPMP3

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 25, 2020
Registry last updated
Jun 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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