Effect of Bromfenac on Pain Related to Pterygium Surgery

Sun Yat-sen University

Status and phase: Completed; Phase 4

Conditions: Pterygium; Pain

Treatments: Drug: 0.1% bromfenac

Study type: Interventional

Funder types: Other

Identifiers

NCT04022811

2018KYPJ101

Details and patient eligibility

About

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).

Full 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 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.

Enrollment: 60 patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Artificial tears

Experimental group

Description:

0.1% bromfenac VS Artificial tears

Treatment:

Drug: 0.1% bromfenac