Dry Eye Syndromes
Conditions
Brief summary
To compare the signs and symptoms of dry eye after cataract surgery between subjects randomized to receive intraoperative dexamethasone in addition to the use of a standard topical post-op treatment regimen.
Detailed description
Forty patients requiring cataract surgery will be randomized to treatment of post-operative inflammation with a single intraoperative dexamethasone injection plus a standard course of topical ophthalmic corticosteroid drops or the standard treatment alone. Dry eye testing will be administered at baseline, 1 week and 3 weeks following surgery.
Interventions
DRUGdexamethasone intraocular suspension, 9%
single dose intracameral corticosteroid
topical ophthalmic steroid drop
Sponsors
SR Cornea Consultants
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Intervention model description
Randomized, controlled prospective study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* undergoing bilateral cataract surgery
Exclusion criteria
* central corneal staining with fluorescein and/or a tear film osmolarity of greater than 340 in either eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively | 3 weeks | Tear Film Osmolarity as measured on Tear Lab system; validated measure of Tear Film Osmolarity Osmolarity was reported in milliosmoles per liter (mOsmol/L) |
Countries
United States
Participant flow
Recruitment details
patients scheduled to undergo bilateral cataract surgery 40 participants were enrolled, each eye was randomized to 2 different treatment groups (intracameral dexamethasone + postoperative topical prednisolone or postoperative topical prednisolone alone)
Pre-assignment details
patients scheduled to undergo bilateral cataract surgery were randomly assigned to receive an intracameral injection of dexamethasone + a standard postoperative topical steroid regimen in one eye, and a standard postoperative topical steroid regimen in the other eye. Preoperative and postoperative signs of dry eye were compared between the two groups
Participants by arm
| Arm | Count |
|---|---|
| Intracameral Dexamethasone + Post-operative Topical Prednisolone dexamethasone intraocular suspension, 9% + topical ophthalmic prednisolone
dexamethasone intraocular suspension, 9%: single dose intracameral corticosteroid
Prednisolone Acetate: topical ophthalmic drop | 40 |
| Intracameral Dexamethasone + Post-operative Topical Prednisolone dexamethasone intraocular suspension, 9% + topical ophthalmic prednisolone
dexamethasone intraocular suspension, 9%: single dose intracameral corticosteroid
Prednisolone Acetate: topical ophthalmic drop | 40 |
| Post-operative Topical Prednisolone topical ophthalmic prednisolone acetate
Prednisolone Acetate: topical ophthalmic drop | 40 |
| Post-operative Topical Prednisolone topical ophthalmic prednisolone acetate
Prednisolone Acetate: topical ophthalmic drop | 40 |
| Total | 160 |
Baseline characteristics
| Characteristic | Intracameral Dexamethasone + Post-operative Topical Prednisolone | Total | Post-operative Topical Prednisolone |
|---|---|---|---|
| Age, Categorical <=18 years | 1 eyes | 2 eyes | 1 eyes |
| Age, Categorical >=65 years | 24 eyes | 48 eyes | 24 eyes |
| Age, Categorical Between 18 and 65 years | 15 eyes | 30 eyes | 15 eyes |
| Age, Continuous | 67.49 years STANDARD_DEVIATION 10.42 | 67.49 years STANDARD_DEVIATION 10.42 | 67.49 years STANDARD_DEVIATION 10.42 |
| Preoperative Tear Film Osmolarity | 307.475 mOsmo/L | 307.625 mOsmo/L | 307.775 mOsmo/L |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 40 eyes | 80 eyes | 40 eyes |
| Sex: Female, Male Female | 22 eyes | 44 eyes | 22 eyes |
| Sex: Female, Male Male | 18 eyes | 36 eyes | 18 eyes |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 40 | 0 / 40 |
| other Total, other adverse events | 0 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively
Tear Film Osmolarity as measured on Tear Lab system; validated measure of Tear Film Osmolarity Osmolarity was reported in milliosmoles per liter (mOsmol/L)
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intracameral Dexamethasone | Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively | 311.15 mOsmol/L |
| Postoperative Prednisolone Acetate | Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively | 316.3 mOsmol/L |
p-value: <0.01ANOVA