Effect of Topical Dexmedetomidine on Intraocular Pressure
Sponsor
Beirut Eye Specialist Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03690622
Collaborator
(none)
49
1
2
4
12.1
Study Details
Study Description
Brief Summary
Evaluate the short-term safety and efficacy of dexmedetomidine (0.0055%) drops on intraocular pressure (IOP) in healthy eyes.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
49 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
randomised control trialrandomised control trial
Masking:
Double (Participant, Investigator)
Masking Description:
masking for the drop instilled
Primary Purpose:
Treatment
Official Title:
The Effect of Topical Dexmedetomidine (0.0055%) on Intraocular Pressure in Healthy Eyes: a Randomized Controlled Trial
Actual Study Start Date
:
Dec 1, 2017
Actual Primary Completion Date
:
Jan 1, 2018
Actual Study Completion Date
:
Apr 3, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: BSS Balanced salt solution |
Drug: Balanced salt solution
instillation of eyedrop
|
| Active Comparator: Dexmedetomidine dexmedetomidine (0.0055%) |
Drug: Dexmedetomidine
Instillation of eyedrops
|
Outcome Measures
Primary Outcome Measures
- Intraocular pressure change [at presentation, 30 minutes, 4 hours and 24 hours after instillation]
Taken by aplanation tonometry
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- Patients with healthy eyes and no history of glaucoma
Exclusion Criteria:
- history of glaucoma, IOP > 24mmHg at baseline, abnormal optic nerve on fundus examination, keratoconus, corneal graft, corneal edema or a history of refractive surgery
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beirut Eye Specialist Hospital | Beirut | Lebanon | 116-5311 |
Sponsors and Collaborators
- Beirut Eye Specialist Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Kim NY, Yoo YC, Park H, Choi YD, Kim CY, Bai SJ. The effect of dexmedetomidine on intraocular pressure increase in patients during robot-assisted laparoscopic radical prostatectomy in the steep Trendelenburg position. J Endourol. 2015 Mar;29(3):310-6. doi: 10.1089/end.2014.0381. Epub 2014 Oct 14.
- Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7.
- Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 2014 Jun 26. Review.
- Vartiainen J, MacDonald E, Urtti A, Rouhiainen H, Virtanen R. Dexmedetomidine-induced ocular hypotension in rabbits with normal or elevated intraocular pressures. Invest Ophthalmol Vis Sci. 1992 May;33(6):2019-23.
- Zhou C, Zhu Y, Liu Z, Ruan L. The Effects of Intravenous Dexmedetomidine Injections on IOP in General Anesthesia Intubation: A Meta-Analysis. Biomed Res Int. 2017;2017:6186832. doi: 10.1155/2017/6186832. Epub 2017 Feb 2.
Responsible Party:
Beirut Eye Specialist Hospital
ClinicalTrials.gov Identifier:
NCT03690622
Other Study ID Numbers:
- BeirutEyeSH
First Posted:
Oct 1, 2018
Last Update Posted:
Oct 3, 2018
Last Verified:
Sep 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: