Effect of Nepafenac on Post-operative Macular Swelling Following Uncomplicated Cataract Surgery

Cystoid Macular Edema Clinical Trial

Official title:

Effect of Nepafenac on Post-operative Cystoid Macular Edema Following Uncomplicated Cataract Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00494494
• Other study ID #: 05-3115
• Status: Completed
• Phase: Phase 4
• First received: June 28, 2007
• Last updated: June 13, 2011
• Start date: June 2007
• Est. completion date: April 2008

Study information

• Verified date: June 2011
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cataract
• Cystoid Macular Edema
• Macular Edema

Intervention

Drug:
• Standard Care
topical antibiotic for 10 days plus topical corticosteroids for 1 month
• nepafenac
liquid drops, administered three times per day for 1 month in addition to standard care use of topical antibiotic and topical corticosteroid

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Research to Prevent Blindness

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups)	The endpoints of the study were change in macular thickness measured by OCT in the central 1mm diameter centred on the fovea (central macular thickness)	baseline and 8 weeks	No
Primary	Pre-operative Best Corrected Visual Acuity (BCVA)	Patients were instructed to read letters on the EDTRS visual acuity chart. The mean and standard deviation for each group was measured. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity.	baseline	No
Primary	Foveal Thickness	difference in mean pre-post changes by the two treatment groups	baseline and 8 weeks	No
Primary	Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups)		baseline and 8 weeks	No
Primary	Post-operative Best Corrected Visual Acuity (BCVA)	The patients were again instructed to read letters on the ETDRS chart 8 weeks post-surgery. The mean and standard deviation for each group was recorded. Letters range from 0 (20/2000) to 110 (20/12.5), with the higher number signaling better visual acuity.	baseline and 8 weeks	No