A Prospective Clinical Study Evaluating Dexycu vs Prednisolone Acetate 1%
NCT ID: NCT04273282
Last Updated: 2020-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
31 participants
INTERVENTIONAL
2019-12-16
2020-11-24
Brief Summary
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Detailed Description
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Dexycu Group: A total of 30 study subjects will have Dexycu intracameral dexamethasone placed in their scheduled surgical eye at the time of surgery and will receive 50 micrograms of intracameral moxifloxacin at the conclusion of the procedure. They will take Prolensa each day after surgery for 4 weeks.
Control Group: A total of 30 study subjects will receive topical moxifloxacin 0.5% four times per day 1 day prior to surgery and for ten days postoperatively, Prolensa every day 1 day prior to surgery and for 4 weeks postoperatively, and prednisolone acetate 1.0% four times per day starting at the conclusion of cataract surgery for 2 weeks and twice per day for 2 weeks in their scheduled surgical eye.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
Dexycu Group:A total of 30 study subjects will have Dexycu intracameral dexamethasone placed in their scheduled surgical eye at the time of surgery and will receive 50 micrograms of intracameral moxifloxacin at the conclusion of the procedure. They will take Prolensa each day after surgery for 4 weeks.
Control Group:A total of 30 study subjects will receive topical moxifloxacin 0.5% 4 times per day 1 day prior to surgery and for 10 days postoperatively, Prolensa every day 1 day prior to surgery and for 4 weeks postoperatively, and prednisolone acetate 1% four times per day starting at the conclusion of cataract surgery for 2 weeks and twice per day for 2 weeks in their scheduled surgical eye.
TREATMENT
SINGLE
Study Groups
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Dexycu Group
A total of 30 study subjects (30 eyes) will have Dexycu intracameral dexamethasone placed in their scheduled surgical eye at the time of surgery and will receive 50 micrograms of intracameral moxifloxacin at the conclusion of the procedure. They will take Prolensa qd after surgery for 4 weeks.
Dexycu intracameral dexamethasone
To evaluate the safety and ocular efficacy of Dexycu.
Control Group
A total of 30 study subjects (30 eyes) will receive topical moxifloxacin 0.5% qid 1 day prior to surgery and for ten days postoperatively, Prolensa qd 1 day prior to surgery and for 4 weeks postoperatively, and prednisolone acetate 1.0% qid starting at the conclusion of cataract surgery for 2 weeks and bid for 2 weeks in their scheduled surgical eye.
Prednisolone Acetate
To evaluate the safety and ocular efficacy, and patient acceptance of post cataract surgery drug treatment regimen that minimizes topical medications.
Interventions
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Dexycu intracameral dexamethasone
To evaluate the safety and ocular efficacy of Dexycu.
Prednisolone Acetate
To evaluate the safety and ocular efficacy, and patient acceptance of post cataract surgery drug treatment regimen that minimizes topical medications.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must be able to comprehend and willing to give informed consent.
* Woman of child-bearing potential must not be pregnant or lactating.
* Subject has availability, willingness, and sufficient cognitive awareness to comply with exam procedures and able to return for all scheduled study visits.
* Subject with cataract for which routine phacoemulsification extraction and implantation of an intraocular lens has been planned.
* Subject with an OCT of the macula in both eyes that demonstrates no significant pathology.
Exclusion Criteria
* Subject with a known sensitivity to any of the study medications.
* Subject with only one eye with potentially good vision.
* Subject that has undergone prior intraocular surgery in the scheduled surgical eye within the last 6 months or laser surgery within three months prior to screening.
* Subject with pupil abnormalities.
* Subject with corneal abnormalities.
* Subject with a history of chronic/recurrent inflammatory eye disease in either eye.
* Subject with uncontrolled glaucoma.
* Subject expected to undergo surgical intervention and/or ocular laser treatment prior to or during the study period.
* Subject who requires use of systemic or ocular medications that may affect vision, ocular inflammation, or pain.
* Subject with an acute or chronic disease or illness that would increase risk or confound study results, e.g. autoimmune disease, etc.
* Subject with an uncontrolled systemic disease.
* Subject with poorly-controlled diabetes.
* Subject currently participating or has participated in another clinical trial within 30 days prior to enrollment.
18 Years
ALL
Yes
Sponsors
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Research Insight LLC
INDUSTRY
Responsible Party
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Principal Investigators
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John Hovanesian, MD
Role: PRINCIPAL_INVESTIGATOR
Research Insight LLC
Locations
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Harvard Eye Associates
Laguna Hills, California, United States
Ophthalmic Consultants of Long Island
Garden City, New York, United States
Countries
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References
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Hovanesian JA, Donnenfeld ED. Intracameral dexamethasone 9% vs prednisolone acetate 1% in controlling postoperative pain and inflammation in patients undergoing cataract surgery. J Cataract Refract Surg. 2022 Aug 1;48(8):906-911. doi: 10.1097/j.jcrs.0000000000000887. Epub 2022 Jan 18.
Other Identifiers
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1909 D3 EyePoint
Identifier Type: -
Identifier Source: org_study_id