Ignite Creation Date:
2024-05-06 @ 3:26 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04633954
Status:
COMPLETED
Last Update Posted:
2020-11-18
First Post:
2020-11-08
Brief Title:
Brimonidine for Subconjunctival Hemorrhage From Femtosecond Laser Assisted Cataract Surgery
Sponsor:
Uptown Eye Specialists
Organization:
Uptown Eye Specialists
Study Overview
Official Title:
The Effect if Brimonidine 015 on the Development of Subconjunctival Hemorrhage Following Femtosecond Laser Assisted Cataract Surgery
Status:
COMPLETED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 015 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
The purpose of this study is to test the use of a well-known eye medication normally for treating glaucoma called Brimonidine tartrate 015 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
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 015 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 015 Subconjunctival hemorrhage and its associated bulbar redness will be measured using Bulbar Redness Score using the Oculus M5 following the surgery
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 015 Subconjunctival hemorrhage and its associated bulbar redness will be measured using Bulbar Redness Score using the Oculus M5 following the surgery
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None