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CompletedNCT03646500Updated Aug 28, 2018

Comparing Conscious Sedation to Retrobulbar Block Anesthetics During Trans-scleral Diode Laser

An interventional study of Retrobulbar Block and Remifentanil in Glaucoma, sponsored by Queen's University. Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-28.

Sponsored by Queen's University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a non-inferiority trial with a prospective randomized controlled design assessing patient satisfaction and complications associated with both retrobulbar block anesthetics (current gold standard) and conscious IV sedation alone (alternative choice of anesthesia) for trans-scleral diode laser (TSD). Patient satisfaction and complications will be measured using standardized patient surveys.

Read the detailed description

This is a non-inferiority trial with a prospective randomized controlled design assessing patient satisfaction and complications associated with both retrobulbar block anesthetics (current gold standard) and conscious IV sedation alone (alternative choice of anesthesia) for trans-scleral diode laser (TSD). Patient satisfaction and complications will be measured using standardized patient surveys.

Methodology:

  1. Patients undergoing TSD would be recruited from one glaucoma subspecialist's practice.
  2. Patient consents to TSD at the eye clinic.
  3. Clinical trial is mentioned to the patient and if there is interest a consent form is given to the patient to look over and develop questions the patient may want to ask.
  4. Pre-anesthesia consult will be conducted to determine eligibility for both conscious sedation and retrobulbar block.
  5. Patient is contacted by phone by the study coordinator to discuss whether the patient is still eligible to be a part of the clinical trial and whether the patient is still interested and if yes, what questions the patient might have. If the patient wishes to meet in person this will be arranged and consent can be obtained at that time, but if the patients are from a far distance then the signing of the consent will happen on the day of the procedure (although the discussion would already have taken place over the phone).
  6. Patients will be randomized to either conscious sedation group, or retrobulbar injection group (control) via an online program.
  7. On the day of the surgery, patients will receive a pre-anesthesia questionnaire (questions include basic identifying, health and surgery information).
  8. Patients will receive a post-surgery questionnaire one hour after the surgery, in the recovery room.
  9. Patients will receive a phone call for a post-recovery questionnaire 24 hours later.
  10. Patients will receive a recovery and complications questionnaire one week later at the clinic (during check-up).
02

Conditions studied

  • Glaucoma

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03

In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's enrollment of 100 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Queen's University is the lead sponsor of 199 studies on the registry; 16 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • ability to consent
  • eligibility for both a conscious sedation and a retrobulbar block (decided through pre-anesthesia consult, which is a standard consult obtained for this procedure)

Exclusion criteria

Exclusion Criteria:

  • pregnancy
  • inability to consent
  • under 18 years of age
  • not eligible for conscious sedation and/or retrobulbar block.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
100 participants (actual)

Study arms

  • Experimental
    Retrobulbar block

    Retrobulbar block administered prior to Transcleral Diode Procedure

    Procedure: Retrobulbar Block

  • Active comparator
    Remifentanil

    Conscious IV sedation administered prior to Transcleral Diode Procedure.

    Procedure: Remifentanil

Interventions

  • ProcedureRetrobulbar Block

    Anesthetic nerve block administered in the retrobulbar space prior to transcleral diode procedure

  • ProcedureRemifentanil

    Remifentanil administered as intravenous infusion prior to transcleral diode procedure

    Also known as: remifentanil hydrochloride

06

What researchers measure

Primary outcomes

  1. Leiden Perioperative Care Patient Satisfaction Questionnaire

    Self reported questionnaire measures patient satisfaction with perioperative care in the following dimensions: Information, Discomfort and Needs, Fear and Concern, Staff-Patient relationship, Service. Information, Staff-Patient Relationship scored as on a 5 point scale: Completely Satisfied, Dissatisfied, Not satisfied, nor dissatisfied, Satisfied, Completely Satisfied. Discomfort and needs and Fear and Concern are scored on a 5 point scale: Not at all, A little bit, Moderately, Quite a bit, Extremely).

    Time frame: 1-week

Secondary outcomes

  1. Core Measures of Outcomes of Anesthesia

    Complication Rates

    Time frame: 1-week

07

Study locations

1 site
  • Hotel Dieu Hospital
    Kingston, Ontario K7L 5G2, Canada
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 28, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03646500
Lead sponsor
Queen's University
Responsible party
Delan Jinapriya (Assistant Professor (Dept. of Ophthalmology); Eye Physician and Surgeon; Glaucoma Subspecialist, Queen's University) — Principal investigator
First posted
Aug 24, 2018
Start date
Jul 2015
Primary completion
Aug 2017
Completion
Oct 2017
Last update
Aug 28, 2018

Study contacts

Delan Jinapriya, MD
principal investigator · Queen's University - School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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