Brimonidine for Subconjunctival Hemorrhage From Femtosecond Laser Assisted Cataract Surgery
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The focus of this study is to assess how the quality of care for patients undergoing Femtosecond laser-assisted cataract surgery (FLACS) can be improved through the application of Brimonidine Tartrate 0.15% prior to the surgery. The surgery consists of the application of a vacuum which can result in subconjunctival hemorrhage, a benign disorder. The importance of this study is due to the considerable alarm and anxiety caused to the patients by the hemorrhage which may cause them to seek our further unnecessary medical help and reduce their ability to return to work or productivity.
During the laser component of FLACS, the operated eye is secured with a suction cup or ring with vacuum that causes significant subconjunctival hemorrhage. Brimonidine is a selective alpha-2-adrenergic agonist that is a commonly used as a topical medication to treat glaucoma. Besides its intraocular pressure lowering effect, it also has a vasoconstrictive effect. This latter effect has been exploited to reduce bleeding in LASIK, cataract surgery, strabismus surgery, as well as intravitreal injections. This study will examine the effectiveness of Brimonidine to reduce subconjunctival hemorrhage during Femtosecond laser-assisted cataract surgery.
Potential side effects of topical application of Brimonidine eye drop may include blurred or loss of vision, burning, dry, or itching eyes, discharge or excessive tearing, disturbed color perception, double vision, halos around lights, headache, itching of the eye, night blindness, overbright appearance of lights, redness of the eye or inner lining of the eyelid, swelling of the eyelid, tearing of the eye, tunnel vision. The risk of this study to the subject is negligible.
To evaluate the degree of subconjunctival hemorrhage occurring in subjects undergoing Femtosecond laser-assisted cataract surgery, following preoperative application of Brimonidine 0.15%. Subconjunctival hemorrhage and its associated bulbar redness will be measured using Bulbar Redness Score using the Oculus M5 following the surgery.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Brimonidine Group Patients in this arm receive an extra drop of brimonidine in addition to routine eye drops prior to femtosecond laser assisted cataract surgery (FLACS) |
Drug: Brimonidine Tartrate 0.15% Oph Soln
One drop of Brimonidine Tartrate 0.15% Oph Soln prior to FLACS
|
| No Intervention: Control Group Patients in this arm only receive routine eye drops prior to femtosecond laser assisted cataract surgery (FLACS) |
Outcome Measures
Primary Outcome Measures
- Bulbar Redness Score [Pre-operatively]
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.
- Bulbar Redness Score [15 minutes post-operatively]
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.
Secondary Outcome Measures
- Analyzed Area [Pre-operatively]
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.
- Analyzed Area [15 minutes post-operatively]
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.
- Attempts of Vacuum [During the operation]
The number of attempts it takes to achieve adequate vacuum as part of FLACS will be recorded
- Duration of surgery [During the operation]
The entire duration (start to end) of the surgery will be recorded
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Uptown Eye Speicialists | Brampton | Ontario | Canada | L6Y0P6 |
Sponsors and Collaborators
- Uptown Eye Specialists
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- Red Eye 1.0