Condition category
Eye Diseases
Date applied
18/10/2005
Date assigned
16/11/2005
Last edited
21/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nathan Congdon

ORCID ID

Contact details

600 N. Wolfe Street
Wilmer 120
Baltimore
21287
United States of America
+1 410 614 5561
ncongdon@jhmi.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Glaucoma is a slowly progressive optic neuropathy which may rarely be seen in children, and is a leading cause of visual loss in adults. The effects of ketamine and sevoflourane, two commonly used anesthetic agents, on intraocular pressure, are not well known. Serial measurements of IOP in patients randomised to one of the two anesthetic agents will be evaluated. Eyes may be glaucomatous or healthy. Confounding variables, including pulse, blood pressure, oxygenation, will be recorded and evaluated.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Glaucoma

Intervention

Intraocular pressure measurements will be recorded in patients with glaucoma and in healthy patients.

Both sevoflourane and ketamine are commonly used anaesthetic agents. Patients will be randomised to one of the two groups unless the anaesthesiologist or patient prefer one of the agents.

Intervention type

Drug

Phase

Not Specified

Drug names

Sevoflourane and ketamine

Primary outcome measures

Change in intraocular pressure after administration of anesthetic agent:
1. How greatly does the IOP change?
2. What percentage of patients in each group have a statistically significant change?

Secondary outcome measures

Effect of pulse, blood pressure, oxygenation, baseline IOP, baseline eye disease on intraocular pressure.

Overall trial start date

01/01/2005

Overall trial end date

30/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Patients undergoing general anesthesia.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Patients unwilling/unable to give informed consent
2. Patients with irregular corneas or other ocular abnormalities not allowing for an adequate IOP measurement

Recruitment start date

01/01/2005

Recruitment end date

30/12/2005

Locations

Countries of recruitment

United States of America

Trial participating centre

600 N. Wolfe Street
Baltimore
21287
United States of America

Sponsor information

Organisation

Wilmer Eye Institute (USA)

Sponsor details

600 N. Wolfe Street
Baltimore
21287
United States of America
+1 410 614 5561
ncongdon@jhmi.edu

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Wilmer Eye Institute (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes