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NCT Number: NCT00494494

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

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.

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Key information

Conditions

CYSTOID MACULAR EDEMA Cataract Eye Diseases Lens Diseases Macular Degeneration Macular Edema Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27517, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard care

Drug

topical antibiotic for 10 days plus topical corticosteroids for 1 month

Nepafenac

Drug

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

Primary outcomes

  1. Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups)

    Time frame: baseline and 8 weeks

    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)

  2. Pre-operative Best Corrected Visual Acuity (BCVA)

    Time frame: baseline

    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.

  3. Foveal Thickness

    Time frame: baseline and 8 weeks

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

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

    Time frame: baseline and 8 weeks

  5. Post-operative Best Corrected Visual Acuity (BCVA)

    Time frame: baseline and 8 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Research to Prevent Blindness

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 29, 2007
Registry last updated
Jul 12, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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