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

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Sun Yat-sen University

Status

Completed

Conditions

Cataract

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02681679
CCPMOH2016-China-1

Details and patient eligibility

About

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.

Full description

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%. 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. Intraoperative miosis may be due to the intraocular effects that occur after femtosecond laser pretreatment. The intraocular tissues may be exposed to laser emissions, and lens proteins can be released into the anterior chamber. Together, these events trigger the release of unwanted cytokines. In a previous study, intraocular prostaglandin concentrations were found to be increased immediately after femtosecond laser pretreatment. Prostaglandins, especially prostaglandin E2 (PGE2), are known to play a role in inflammation-induced miosis. Preoperative topical treatment with NSAIDs inhibits the release of prostaglandins in response to surgically-induced miosis by suppressing cyclooxygenase, the enzyme that transforms arachidonic acid into prostaglandin precursors. The effectiveness of ophthalmic NSAIDs in preventing miosis has been well documented in conventional phacoemulsification cataract surgery. However, whether this effect is also applicable to femtosecond laser-assisted cataract surgery is unknown. Yeoh has suggested the addition of NSAID eye drops to the dilation regimen during femtosecond laser cataract surgery, but no randomized study has been conducted to support this theory. Given the increasing popularity of femtosecond laser-assisted cataract surgery, the investigators sought to study whether topical NSAIDs might be beneficial in pupil maintenance and PGE2 inhibition during the procedure.

Enrollment

60 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 2 patient groups, including a placebo group

0.1% bromfenac ophthalmic solution
Experimental group
Description:
Patients received 0.1% bromfenac ophthalmic solution twice a day for 3 days before surgery.
Treatment:
Drug: 0.1% bromfenac ophthalmic solution
Procedure: femtosecond laser cataract surgery
control physiological normal saline
Placebo Comparator group
Description:
Patients received control physiological normal saline twice a day for 3 days before surgery.
Treatment:
Procedure: femtosecond laser cataract surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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