Pseudophakic Cystoid Macular Lesions After Uncomplicated Standard Phacoemulsification

Pseudophakic Cystoid Macular Lesions After Uncomplicated Standard Phacoemulsification Clinical Trial

Official title:

Pseudophakic Cystoid Macular Lesions After Uncomplicated Standard Phacoemulsification

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03106402
• Other study ID #: KyungpookNUH
• Status: Completed
• Phase: N/A
• First received: April 3, 2017
• Last updated: April 3, 2017
• Start date: October 1, 2013
• Est. completion date: July 30, 2015

Study information

• Verified date: April 2017
• Source: Kyungpook National University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 316
• Est. completion date: July 30, 2015
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Pseudophakic Cystoid Macular Lesions After Uncomplicated Standard Phacoemulsification

Intervention

Drug:
• topical bromfenac sodium hydrate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Kyungpook National University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of CMLs		12 weeks