Cataract Surgery Clinical Trial
Official title:
The Effect if Brimonidine 0.15% on the Development of Subconjunctival Hemorrhage Following Femtosecond Laser Assisted Cataract Surgery
Verified date | November 2020 |
Source | Uptown Eye Specialists |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Laser-assisted cataract surgery is a common and precise procedure done to remove cataracts from the eye. This procedure involves putting on a suction cup that applies a mild vacuum seal around the eye to stabilize the eye during the laser procedure. This suction cup often causes some bleeding under the conjunctiva around the eye which takes a few days to disappear. The purpose of this study is to test the use of a well-known eye medication (normally for treating glaucoma) called Brimonidine tartrate 0.15% (or Alphagan-P) in patients having laser-assisted cataract surgery. The use of Brimonidine to reduce bleeding under the conjunctiva is investigational, which means it has not been approved by Health Canada for use outside of research studies like this one. This study will see if Brimonidine will help to reduce bleeding under the conjunctiva in patients having laser-assisted cataract surgery.
Status | Completed |
Enrollment | 56 |
Est. completion date | August 31, 2019 |
Est. primary completion date | August 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - All patients who are schedules for femtosecond laser assisted cataract surgery who have provided informed consent, in accordance with application regulations and guidelines Exclusion Criteria: - Patients who have been on anticoagulation or antiplatelet therapy - Patients who have undergone any conjunctival surgery in the past - Any complication during cataract extraction |
Country | Name | City | State |
---|---|---|---|
Canada | Uptown Eye Speicialists | Brampton | Ontario |
Lead Sponsor | Collaborator |
---|---|
Uptown Eye Specialists |
Canada,
Desco MC, Navea A, Ferrer E, Menezo JL. Effect of prophylactic brimonidine on bleeding complications after cataract surgery. Eur J Ophthalmol. 2005 Mar-Apr;15(2):228-32. — View Citation
Hong S, Kim CY, Seong GJ, Han SH. Effect of prophylactic brimonidine instillation on bleeding during strabismus surgery in adults. Am J Ophthalmol. 2007 Sep;144(3):469-70. — View Citation
Kim CS, Nam KY, Kim JY. Effect of prophylactic topical brimonidine (0.15%) administration on the development of subconjunctival hemorrhage after intravitreal injection. Retina. 2011 Feb;31(2):389-92. doi: 10.1097/IAE.0b013e3181eef28e. — View Citation
Norden RA. Effect of prophylactic brimonidine on bleeding complications and flap adherence after laser in situ keratomileusis. J Refract Surg. 2002 Jul-Aug;18(4):468-71. — View Citation
Pasquali TA, Aufderheide A, Brinton JP, Avila MR, Stahl ED, Durrie DS. Dilute brimonidine to improve patient comfort and subconjunctival hemorrhage after LASIK. J Refract Surg. 2013 Jul;29(7):469-75. doi: 10.3928/1081597X-20130617-05. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Bulbar Redness Score | Bulbar redness score measured with Oculus 5M Keratograph will detect the amount of redness before and after FLACS. The Oculus Keratograph 5M BR score uses a clinical grading scale of 0.0-4.0 in 0.1 step. A higher score correlates to increased bulbar redness. | Pre-operatively | |
Primary | Bulbar Redness Score | Bulbar redness score measured with Oculus 5M Keratograph will detect the amount of redness before and after FLACS. The Oculus Keratograph 5M BR score uses a clinical grading scale of 0.0-4.0 in 0.1 step. A higher score correlates to increased bulbar redness. | 15 minutes post-operatively | |
Secondary | Analyzed Area | Bulbar redness scoring by Oculus 5M Keratograph imaging simultaneously calculates the area analyzed, which will be compared between groups to ensure a similar surface area is measured. | Pre-operatively | |
Secondary | Analyzed Area | Bulbar redness scoring by Oculus 5M Keratograph imaging simultaneously calculates the area analyzed, which will be compared between groups to ensure a similar surface area is measured. | 15 minutes post-operatively | |
Secondary | Attempts of Vacuum | The number of attempts it takes to achieve adequate vacuum as part of FLACS will be recorded | During the operation | |
Secondary | Duration of surgery | The entire duration (start to end) of the surgery will be recorded | During the operation |
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