Cystoid Macular Edema
Conditions
Keywords
cystoid macular edema, cataract, nonsteroidal antiinflammatory drugs, optical coherence tomography
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.
Interventions
DRUGStandard Care
topical antibiotic for 10 days plus topical corticosteroids for 1 month
DRUGnepafenac
liquid drops, administered three times per day for 1 month in addition to standard care use of topical antibiotic and topical corticosteroid
Sponsors
Research to Prevent Blindness
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups) | 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) |
| Pre-operative Best Corrected Visual Acuity (BCVA) | 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. |
| Foveal Thickness | baseline and 8 weeks | difference in mean pre-post changes by the two treatment groups |
| Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups) | baseline and 8 weeks | — |
| Post-operative Best Corrected Visual Acuity (BCVA) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard Treatment These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid. | 40 |
| Nepafenac 1 drop per study eye three times per day for 30 days plus standard care | 39 |
| Total | 79 |
Baseline characteristics
| Characteristic | Standard Treatment | Nepafenac | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 40 Participants | 39 Participants | 79 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age Continuous | 70.33 years STANDARD_DEVIATION 8.04 | 73.95 years STANDARD_DEVIATION 8.99 | 72.14 years STANDARD_DEVIATION 8.52 |
| Region of Enrollment United States | 40 participants | 39 participants | 79 participants |
| Sex: Female, Male Female | 19 Participants | 18 Participants | 37 Participants |
| Sex: Female, Male Male | 21 Participants | 21 Participants | 42 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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)
Time frame: baseline and 8 weeks
Population: Three subjects in the treatment group and two subjects in the control group had unreliable preoperative OCT scans because of dense posterior subcapsular cataracts. These subjects were excluded from the analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Treatment | Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups) | 2.78 microns |
| Nepafenac | Central Macular Thickness (Difference in Mean Pre-post Changes by the Two Treatment Groups) | 5.6 microns |
Comparison: The null hypothesis is that there is no correlation between the 2 groups. Standard methods were used for power calculation to determine the sample size needed to have 0.90 power for the comparison between two groups at the two-sided significance of 0.05.p-value: 0.702995% CI: [-3.27, 8.91]Wilcoxon (Mann-Whitney)
Primary
Foveal Thickness
difference in mean pre-post changes by the two treatment groups
Time frame: baseline and 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Treatment | Foveal Thickness | -2.0 microns |
| Nepafenac | Foveal Thickness | 4.7 microns |
p-value: 0.506695% CI: [-3.12, 16.52]Wilcoxon (Mann-Whitney)
Primary
Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups)
Time frame: baseline and 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Treatment | Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups) | 0.05 microns |
| Nepafenac | Macular Volume (Difference in Mean Pre-post Changes by the Two Treatment Groups) | 0.10 microns |
p-value: 0.509995% CI: [-0.13, 0.227]Wilcoxon (Mann-Whitney)
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.
Time frame: baseline and 8 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Standard Treatment | Post-operative Best Corrected Visual Acuity (BCVA) | 54.46 letters |
| Nepafenac | Post-operative Best Corrected Visual Acuity (BCVA) | 55.49 letters |
p-value: 0.500595% CI: [-1.49, 3.55]Wilcoxon (Mann-Whitney)
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.
Time frame: baseline
Population: The analysis was per protocol. At baseline, everybody was given a Best Corrected Visual Acuity Assessment (BCVA).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard Treatment | Pre-operative Best Corrected Visual Acuity (BCVA) | 38.48 letters | Standard Deviation 9.83 |
| Nepafenac | Pre-operative Best Corrected Visual Acuity (BCVA) | 40.49 letters | Standard Deviation 9.56 |
p-value: 0.193795% CI: [-2.41, 6.43]Wilcoxon (Mann-Whitney)