Topical 0.1% Bromfenac Sodium and Prostaglandin E2 Inhibition in Cataract Surgery

NCT02681679 | Completed DMC

• 1 other identifier: CCPMOH2016-China-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Since a new generation of femtosecond lasers became available for cataract surgery in 2009, the use of this image-guided system has provided several benefits, including a reduction in phacoemulsification energy by prefragmentation of the crystalline lens, and the potential advantages of more precise corneal incisions and capsulotomy formation. However, as with any new surgical technique, femtosecond laser cataract surgery also has potential complications. Intraoperative miosis is one of the most common intraoperative complications of femtosecond laser-assisted cataract surgery, with a reported prevalence ranging from 9.5 to 32.0%.8 Significant pupillary constriction necessitates the removal of the anterior capsule flap, fragmented nucleus and remaining cortex, which is potentially associated with a higher rate of surgery-related complications.

Conditions

Cataract

Outcome Measures

Primary Outcomes (2)

• Pupil area measured using ImageJ software A

  surgery

• PGE2 levels measured with an enzyme-linked immunoassay

  2 days after surgery

Study Arms (2)

0.1% bromfenac ophthalmic solution

EXPERIMENTAL

Patients received 0.1% bromfenac ophthalmic solution twice a day for 3 days before surgery.

Drug: 0.1% bromfenac ophthalmic solution; Procedure: femtosecond laser cataract surgery

control physiological normal saline

PLACEBO COMPARATOR

Patients received control physiological normal saline twice a day for 3 days before surgery.

Procedure: femtosecond laser cataract surgery

Interventions

0.1% bromfenac ophthalmic solution DRUG

0.1% bromfenac ophthalmic solution

femtosecond laser cataract surgery PROCEDURE

0.1% bromfenac ophthalmic solution; control physiological normal saline

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• if they were 50 years of age or older and were scheduled to undergo femtosecond laser cataract surgery

You may not qualify if:

• a previous history of intraocular surgery;
• recent trauma;
• uveitis;
• systemic disease, such as diabetes mellitus; hypertension;
• the use of systemic or topical NSAIDs within 1 week of enrollment.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Ministry of Health, China: collaborator

Study Sites (1)

Zhongshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

Location

Related Publications (1)

• Nagy Z, Takacs A, Filkorn T, Sarayba M. Initial clinical evaluation of an intraocular femtosecond laser in cataract surgery. J Refract Surg. 2009 Dec;25(12):1053-60. doi: 10.3928/1081597X-20091117-04.

  PMID: 20000286 BACKGROUND

Related Links

• Home page of Zhongshan Ophthalmic Center

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Haotian Lin, M.D. Ph.D

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator, Childhood Cataract Program of the Chinese Ministry of Health(CCPMOH), Zhongshan Ophthalmic Center

Study Record Dates

• First Submitted: February 10, 2016
• First Posted: February 12, 2016
• Study Start: October 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 12, 2016

Record last verified: 2016-02

Locations

CN (1)