Pseudophakic Cystoid Macular Lesions After Uncomplicated Standard Phacoemulsification

To assess the incidence, risk factors and clinical courses of cystic macular lesions (CMLs) after uncomplicated phacoemulsification and evaluate the efficacy of topical NSAIDs on the prevention of pseudophakic cystic macular lesions

Study Overview

• Status: Completed
• Conditions: Pseudophakic Cystoid Macular Lesions After Uncomplicated Standard Phacoemulsification
• Intervention / Treatment: Drug: topical bromfenac sodium hydrate

Detailed Description

344 Patients undergoing uncomplicated standard phacoemulsification at Kyungpook National University Hospital from 2013 to 2015 were reviewed. CMLs, which is any cystic fluid collections after cataract surgery, were confirmed by preoperative and postoperative optical coherence tomography(OCT) on preoperative, postoperative 1month and 3months examinations. CMLs were classified into two groups: cystic macular edema(CME) and microcystic macular edema(MME).

• Study Type: Observational
• Enrollment (Actual): 316

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This retrospective chart review was of consecutive patients who had phacoemulsification and were treated postoperatively at the Kyungpook National University Hospital, Daegu, Korea, from Oct 2013 to June 2015.

Description

Inclusion Criteria:

• patients who had phacoemulsification and were treated postoperatively at the Kyungpook National University Hospital, Daegu, Korea, from Oct 2013 to June 2015.

Exclusion Criteria:

• patients had complicated cataract surgery (eg, significant corneal edema, posterior capsule rupture, vitreous loss, dropped nuclear material, retained cortical material, or an IOL not placed in the capsular bag)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treated with topical NSAID; 197 eyes of - patients were treated with topical bromfenac sodium hydrate (Bronuck®, Taejoon Pharm. LTD.) 2times a day starting 1 day before surgery and continued for 2 weeks after surgery.	Drug: topical bromfenac sodium hydrate
Treated without topical NSAID; 147 eyes did not receive topical NSAID after cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of CMLs	12 weeks

Collaborators and Investigators

• Sponsor: Kyungpook National University Hospital
• Investigators: Principal Investigator: Hong Kyun Kim, M.D. PhD, Kyungpook National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2013
• Primary Completion (Actual): June 30, 2015
• Study Completion (Actual): July 30, 2015

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: April 3, 2017
• First Posted (Actual): April 10, 2017

Study Record Updates

• Last Update Posted (Actual): April 10, 2017
• Last Update Submitted That Met QC Criteria: April 3, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Bromfenac
• Other Study ID Numbers: KyungpookNUH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No