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NCT03690622 Clinical Trial

Effect of Topical Dexmedetomidine on Intraocular Pressure

Glaucoma Clinical Trial

Official title:
The Effect of Topical Dexmedetomidine (0.0055%) on Intraocular Pressure in Healthy Eyes: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03690622
Other study ID # BeirutEyeSH
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date December 1, 2017
Est. completion date April 3, 2018

Study information
Verified date September 2018
Source Beirut Eye Specialist Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluate the short-term safety and efficacy of dexmedetomidine (0.0055%) drops on intraocular pressure (IOP) in healthy eyes.

Recruitment information / eligibility
Status Completed
Enrollment 49
Est. completion date April 3, 2018
Est. primary completion date January 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dexmedetomidine
Instillation of eyedrops
• Balanced salt solution
instillation of eyedrop

Locations
Country Name City State
Lebanon Beirut Eye Specialist Hospital Beirut

Sponsors (1)
Lead Sponsor Collaborator
Beirut Eye Specialist Hospital

Country where clinical trial is conducted

Lebanon, 

References & Publications (5)

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. — View Citation

Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Intraocular pressure change Taken by aplanation tonometry at presentation, 30 minutes, 4 hours and 24 hours after instillation
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