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

NCT00494494 | Completed Phase 4 Results DMC

• 1 other identifier: 05-3115
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystoid Macular Edema

Keywords

cystoid macular edema; cataract; nonsteroidal antiinflammatory drugs; optical coherence tomography

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• Foveal Thickness

  difference in mean pre-post changes by the two treatment groups

  baseline and 8 weeks

• Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups)

  baseline and 8 weeks

• 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

Study Arms (2)

Standard Treatment

ACTIVE COMPARATOR

topical antibiotic for 10 days and a topical corticosteroid for 1 month

Drug: Standard Care

Nepafenac

EXPERIMENTAL

1 drop per study eye three times per day for 30 days in addition to standard care

Drug: nepafenac

Interventions

Standard Care DRUG

topical antibiotic for 10 days plus topical corticosteroids for 1 month

Standard Treatment

nepafenac DRUG

liquid drops, administered three times per day for 1 month in addition to standard care use of topical antibiotic and topical corticosteroid

Nepafenac

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over age 50
• having cataract surgery at UNC

You may not qualify if:

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Research to Prevent Blindness: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27517, United States

Location

MeSH Terms

Conditions

Macular Edema; Cataract

Interventions

Standard of Care; nepafenac

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Lens Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

Although the peak incidence of CME is said to be at 4-12 weeks after surgery, we may have missed the time course for detecting the maximum increased OCT measured macular thickness.

Results Point of Contact

• Title: Kennth L. Cohen, MD
• Organization: University of North Carolina at Chapel Hill

klc@med.unc.edu

919 843-0292

Study Officials

• Kenneth C Cohen, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 28, 2007
• First Posted: June 29, 2007
• Study Start: June 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: July 12, 2011
• Results First Posted: July 12, 2011

Record last verified: 2011-06

Locations

US (1)