Effect of Bromfenac on Pain Related to Pterygium Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-10-31

Brief Summary

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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 membrane transplantation(AMT).

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Detailed Description

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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 evaluated with the visual analog scale(VAS) and present pain index(PPI) with the short form of the McGill Pain Questionnaire. psychological state used Self-rating of Depression Scale(SDS) and Self-rating of Anxiety Scale (SAS) to assess. Ocular inflammation was assessed with an automated bulbar redness grading technique. The irritative symptoms evaluation was carried out by an independent investigator at each visit with questionnaires of ocular symptom scores(OSS). Corneal epithelial healing rate was calculated after following up. All patients had follow-ups at the day 1, day 3, day7 and day 10.

Conditions

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Pterygium Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Artificial tears

0.1% bromfenac VS Artificial tears

Group Type EXPERIMENTAL

0.1% bromfenac

Intervention Type DRUG

the patients received the use of the Ponacore 3 days before and 7 days after the operation. Local eye drops, 2 times a day.

Interventions

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0.1% bromfenac

the patients received the use of the Ponacore 3 days before and 7 days after the operation. Local eye drops, 2 times a day.

Intervention Type DRUG

Other Intervention Names

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0.5%Tobramycin dexamethasone 0.3% sodium hyaluronate

Eligibility Criteria

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Inclusion Criteria

1. Patients with unilateral or double pterygium
2. The gender is not limited, age 45-75 years old
3. intraocular pressure \<21mmHg
4. follow the preoperative and postoperative drug regimen and ensure regular follow-up

Exclusion Criteria

1. Patient factors: lack of cooperation and poor compliance.
2. Severe dry eye, Sjogren's syndrome, cicatricial pemphigoid, and other systemic diseases that seriously affect the structure or function of the ocular surface.
3. Glaucoma or high intraocular pressure (above 21 mmHg), active uveitis, retinal detachment and other diseases.
4. 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.
5. 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).
6. 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.

Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No