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Status:

COMPLETED

Effect of Bromfenac on Pain Related to Pterygium Surgery

Lead Sponsor:

Zhongshan Ophthalmic Center, Sun Yat-sen University

Conditions:

Pterygium

Pain

Eligibility:

All Genders

45-75 years

Phase:

PHASE4

Brief Summary

To evaluate the efficacy and ocular safety of bromfenac ophthalmic solution (bromfenac) 0.1% dosed twice daily for the treatment of ocular inflammation and pain after pterygium excision with amniotic ...

Detailed Description

Patients scheduled to undergo pterygium excision with AMT were randomized to receive added topical bromfenac or artificial lacrima at 3 days before and 7 days after the surgery. Pain intensity was eva...

Eligibility Criteria

Inclusion

  • Inclusion criteria
  • Patients with unilateral or double pterygium
  • The gender is not limited, age 45-75 years old
  • intraocular pressure \<21mmHg
  • follow the preoperative and postoperative drug regimen and ensure regular follow-up
  • Exclusion Criteria
  • Patient factors: lack of cooperation and poor compliance.
  • Severe dry eye, Sjogren's syndrome, cicatricial pemphigoid, and other systemic diseases that seriously affect the structure or function of the ocular surface.
  • Glaucoma or high intraocular pressure (above 21 mmHg), active uveitis, retinal detachment and other diseases.
  • History of systemic diseases, such as uncontrolled diabetes and hypertension, rosacea, severely impaired cardiopulmonary function or other diseases that cannot tolerate surgery; central nervous system disorders affect patient perception, trigeminal neuritis, trigeminal neuralgia, and tongue Pharyngeal neuralgia, migraine and period of toothache attack.
  • history of drug allergies, such as NSAID drugs, tobramycin, anesthetics and so on. Smokers and alcoholics (smoking volume \>15 cigarettes/day, pure alcohol consumption\>100 ml/week).
  • Other history of eye surgery, such as history of eye trauma, history of glaucoma surgery, history of cataract surgery, history of retinal surgery, or other serious injuries to the eyelids, conjunctiva, cornea, and other tissues of the eye surface.

Exclusion

    Key Trial Info

    Start Date :

    October 1 2016

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2017

    Estimated Enrollment :

    60 Patients enrolled

    Trial Details

    Trial ID

    NCT04022811

    Start Date

    October 1 2016

    End Date

    October 1 2017

    Last Update

    July 17 2019

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Zhongshan Opthalmic Center

    Guangzhou, Guangdong, China, 510000

    2

    Zhongshan Ophthalmic Center, Sun Yat-Sen University

    Guangzhou, Guangdong, China, 510080