Cystoid Macular Edema
Conditions
Brief summary
Prospective, randomized, double-masked, placebo-controlled clinical study to define the effective use of a topical non-steroidal anti-inflammatory drug added to topical steroid use after uncomplicated phacoemulsification for the prevention of pseudophakic cystoid macular edema.
Interventions
DRUGNepafenac 0.3%
DRUGSaline Solution
Sponsors
Intuor Technologies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects, 18 and older subjects with visually significant cataracts and were to undergo phacoemulsification with implantation of an intracapsular positioned intraocular lens.
Exclusion criteria
* previous uveitis (\<1 year) previous anterior segment intraocular surgery hypersensitivity or allergy to NSAIDs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Clinical Findings of Cystoid Macular Edema | 6 weeks | post-operative macular volume (mm) |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nepafenac 0.3% nepafenac 0.3% ophthalmic solution dosed once daily
Nepafenac 0.3% | 331 |
| Nepafenac 0.3% nepafenac 0.3% ophthalmic solution dosed once daily
Nepafenac 0.3% | 500 |
| Saline Solution sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily
Saline Solution | 331 |
| Saline Solution sterile saline drops with a pH approximately of 7.0 and osmolality of 290 mOsm/kg, dosed at once daily
Saline Solution | 500 |
| Total | 1,662 |
Baseline characteristics
| Characteristic | Nepafenac 0.3% | Saline Solution | Total |
|---|---|---|---|
| Age, Continuous | 68.8 years | 67.9 years | 68.3 years |
| Macular volume | 8.7 mm STANDARD_DEVIATION 0.15 | 8.75 mm STANDARD_DEVIATION 0.15 | 8.72 mm STANDARD_DEVIATION 0.15 |
| Sex: Female, Male Female | 182 Participants | 182 Participants | 364 Participants |
| Sex: Female, Male Male | 149 Participants | 149 Participants | 298 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 331 | 0 / 331 |
| serious Total, serious adverse events | 0 / 331 | 0 / 331 |
Outcome results
Primary
Post-operative Clinical Findings of Cystoid Macular Edema
post-operative macular volume (mm)
Time frame: 6 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nepafenac 0.3% | Post-operative Clinical Findings of Cystoid Macular Edema | 8.85 mm | Standard Deviation 0.13 |
| Saline Solution | Post-operative Clinical Findings of Cystoid Macular Edema | 8.95 mm | Standard Deviation 0.18 |