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Topical Bromfenac for Intraoperative Miosis and Pain Reduction

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ClinicalTrials.gov Identifier: NCT03831984
Recruitment Status : Enrolling by invitation
First Posted : February 6, 2019
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
Maria Camila Aguilar Sierra, Hospital de La Luz

Brief Summary:
To evaluate the effect of bromfenac ophthalmic solution 0.09% for reduction of intraoperative miosis and pain in patient who have undergone femtosecond laser-assisted cataract surgery.

Condition or disease Intervention/treatment Phase
Cataract Drug: 0,09% Bromfenac Drug: 0,1% sodium hyaluronate Phase 4

Detailed Description:
This prospective cross-sectional randomized clinical study included 60 patients with senile cataract in the absence of significant ocular comorbidity. The patients received 0.09% bromfenac ophthalmic solution or control placebo twice a day for 3 days before surgery. Pupil diameter was measured at the initiation and finalization of femtosecond laser-assisted cataract surgery and pain quantification was assessed by analogous pain scale at one day follow-up.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Topical 0,09% Bromfenac for Intraoperative Miosis and Pain Reduction in Femtosecond Laser-assisted Cataract Surgery
Actual Study Start Date : March 1, 2018
Actual Primary Completion Date : November 30, 2018
Estimated Study Completion Date : March 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Active Comparator: 0,09% Bromfenac
Topical 0,09% Bromfenac twice daily 3 days before surgery
Drug: 0,09% Bromfenac
topical 0,09% Bromfenac, one drop twice daily 3 days before surgery
Other Name: Zebesten

Placebo Comparator: 0,1% sodium hyaluronate
Topical 0,1% sodium hyaluronate twice daily 3 days before surgery
Drug: 0,1% sodium hyaluronate
topical 0,1% sodium hyaluronate, one drop twice daily 3 days before surgery
Other Name: Hyabak




Primary Outcome Measures :
  1. intraoperative miosis [ Time Frame: 2 days ]
    Evaluation of reduction of intraoperative miosis before and after femtosecond laser assisted cataract surgery


Secondary Outcome Measures :
  1. postoperative pain [ Time Frame: 1 day ]
    Evaluation of reduction of postoperative pain using a visual analogue scale



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female
  • Subjects 18 years or older
  • Patients scheduled for unilateral femtosecond laser-assisted cataract surgery cataract surgery with posterior chamber (PC) IOL implantation.

Exclusion Criteria:

  • Presence of corneal abnormalities
  • History of intraocular surgery
  • History of ocular or systematic diseases (glaucoma, diabetes, uveitis
  • Regular, systemic use of steroid or NSAIDs during the previous 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03831984


Locations
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Mexico
Maria Camila Aguilar Sierra
Ciudad de Mexico, Mexico, 06030
Sponsors and Collaborators
Hospital de La Luz
Investigators
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Principal Investigator: MARIA AGUILAR SIERRA, MD FELLOWSHIP

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Responsible Party: Maria Camila Aguilar Sierra, MD, Hospital de La Luz
ClinicalTrials.gov Identifier: NCT03831984     History of Changes
Other Study ID Numbers: MAguilarSierra
First Posted: February 6, 2019    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Maria Camila Aguilar Sierra, Hospital de La Luz:
Phacoemulsification
femtosecond laser
bromfenac
NSAID
pupil
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases
Bromfenac
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents