Clinical trial NCT00494494: Effect of Nepafenac on Post-operative Macular Swelling Following Uncomplicated Cataract Surgery
Official title: Effect of Nepafenac on Post-operative Cystoid Macular Edema Following Uncomplicated Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cystoid Macular Edema
Keywords: cystoid macular edema
cataract
nonsteroidal antiinflammatory drugs
optical coherence tomography
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Research to Prevent Blindness
First posted: 2007-06-29
Enrollment: 82
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Purpose: Study the effect of nepafenac ophthalmic suspension 0.1% to prevent post-operative cystoid macular edema following uncomplicated cataract surgery

Participants: Patients having cataract surgery at UNC who meet eligibility criteria

Procedures (methods): Patients will have pre and post-operative vision measured and optical coherence tomography (OCT) testing, also cataract density and intraoperative phacoemulsification parameters including ultrasound power and ultrasound time will be measured. Patients will be randomized into two groups. Group 1 will be treated with standard post-operative cataract management. Group 2 will be treated with standard post-operative cataract management plus topical nepafenac for one month. Post-operative macular thickness will be studied by analyzing the visual acuity and OCT measurements at two months post surgery.

Detailed description: We plan to enroll 80 patients in this prospective randomized clinical trial. Eligible patients will be randomized into two groups. All patients will have pre-operative Early Treatment of Diabetic Retinopathy Study (ETDRS) vision measured and pre-operative OCT (Humphrey-Zeiss Medical Systems, San Leandro, CA) in both eyes. OCT measurements will include total macular volume, central foveal thickness, and average macular thickness. Pre-operatively, all cataracts will be graded using the LOCS III classification system.10 Group 1 will receive pre-operative topical nepafenac to maintain intra-operative pupillary dilation which is standard care for cataract surgery. Following surgery Group 1 will be treated with standard post operative cataract treatment, including a topical antibiotic and a topical corticosteroid. Group 2 will also receive pre-operative topical nepafenac to maintain intra-operative pupillary dilation. Following surgery patients in Group 2 will be treated with topical nepafenac, a topical antibiotic, and a topical corticosteroid. Group 2 will be given the 3ml bottle of nepafenac to take home and instructed to use it three times per day for one month. Intra-operative surgical parameters including ultrasound time and average percent phacoemulsification power will be recorded for all surgeries. All patients will be seen on post-operative day one, one week, one month, and two months. At the two month visit, best corrected ETDRS vision and OCT will be repeated in both eyes. The two month visual acuity and post-operative OCT will be analyzed to evaluate the effect of nepafenac on CME following cataract surgery. Wilcoxon signed rank test will be used to compare pre-operative and post-operative differences between visual acuity and OCT measurements. The Spearman correlation will be used to compare the variables in the study including cataract density, ultrasound time, average percent phacoemulsification power, and OCT measurements.

Eligibility criteria: Inclusion Criteria:

* over age 50
* having cataract surgery at UNC

Exclusion Criteria:

* medically controlled diabetes
* history of intraocular surgery
* abnormal pre-op optical coherence tomography scan
* history of ocular inflammation
* have age related macular degeneration

Primary outcomes:
measure: Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups)
timeFrame: baseline and 8 weeks
measure: Pre-operative Best Corrected Visual Acuity (BCVA)
timeFrame: baseline
measure: Foveal Thickness
timeFrame: baseline and 8 weeks
measure: Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups)
timeFrame: baseline and 8 weeks
measure: Post-operative Best Corrected Visual Acuity (BCVA)
timeFrame: baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Kenneth C Cohen, MD
role: PRINCIPAL_INVESTIGATOR
References: