A Prospective Trial Evaluating a Intracanalicular Insert Delivery System Compared to Traditional Topical Drops in Controlling Post-operative Pain and inFlammation in Subjects Undergoing Sequential Bilateral Cataract Surgery
Ophthalmic Consultants of Long Island
Summary
To evaluate the safety and ocular efficacy of Dextenza in combination with an intracameral antibiotic and NSAID in controlling post-operative ocular pain and inflammation compared to standard of care topical therapy in patients undergoing bilateral cataract surgery.
Description
This is a randomized, self-controlled prospective clinical study. On initial consultation within one month of scheduled cataract surgery, each study subject will be randomized by a random number generator to receive one of two treatment groups, either experimental or control in the first eye. The second eye will undergo cataract surgery 2 weeks later and will be treated with the other treatment group: Experimental Group: A total of 50 study subjects (50 eyes) will receive Dextenza dexamethasone intracanalicular insert placed in the lower punctum of their scheduled surgical eye at the time of…
Eligibility
- Age range
- 22–100 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * A male or female subject in good general health (as determined by the Investigator), \> 22 years of age at the time of the screening visit * A subject must be willing and able to sign informed consent * A woman of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test at screening and must be practicing an adequate method of birth control. Acceptable methods of birth control include intrauterine device (IUD), oral, dermal ("patch"), implant or injected contraceptives; tubal ligation; and barrier methods with spermicide. * A subject…
Interventions
- DrugDexamethasone
Drugs to be administer during cataract surgery to experimental group
- OtherStandard of care surgery
Standard method used for surgery and the use of post operative drops
Location
- Ophthalmic Consultants of Long IslandGarden City, New York