Brimonidine for Subconjunctival Hemorrhage From Femtosecond Laser Assisted Cataract Surgery

November 16, 2020 updated by: Sohel Somani, Uptown Eye Specialists

The Effect if Brimonidine 0.15% on the Development of Subconjunctival Hemorrhage Following Femtosecond Laser Assisted Cataract Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Brampton, Ontario, Canada, L6Y0P6
        • Uptown Eye Speicialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bulbar Redness Score
Time Frame: 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.
Pre-operatively
Bulbar Redness Score
Time Frame: 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.
15 minutes post-operatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analyzed Area
Time Frame: 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.
Pre-operatively
Analyzed Area
Time Frame: 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.
15 minutes post-operatively
Attempts of Vacuum
Time Frame: During the operation
The number of attempts it takes to achieve adequate vacuum as part of FLACS will be recorded
During the operation
Duration of surgery
Time Frame: During the operation
The entire duration (start to end) of the surgery will be recorded
During the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uptown Eye Specialists

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2019

Primary Completion (Actual)

August 31, 2019

Study Completion (Actual)

August 31, 2019

Study Registration Dates

First Submitted

November 8, 2020

First Submitted That Met QC Criteria

November 16, 2020

First Posted (Actual)

November 18, 2020

Study Record Updates

Last Update Posted (Actual)

November 18, 2020

Last Update Submitted That Met QC Criteria

November 16, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Red Eye 1.0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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