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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intracameral dexamethasone 9% + postoperative topical prednisolone acetate | Experimental | dexamethasone intraocular suspension, 9% injected intracamerally at the time of cataract surgery + topical ophthalmic prednisolone acetate for 3 weeks post-operatively |
|
| postoperative topical prednisolone acetate | Active Comparator | topical ophthalmic prednisolone acetate for 3 weeks post-operatively |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dexamethasone intraocular suspension, 9% | Drug | single dose intracameral corticosteroid |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sanjay Rao, MD | SR Cornea Conslutants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hauser Ross Surgical Center | Sycamore | Illinois | 60178 | United States |
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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
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)
| ID | Title | Description |
|---|---|---|
| FG000 | Intracameral Dexamethasone + Postoperative Topical Prednisolone | dexamethasone intraocular suspension, 9% + topical ophthalmic prednisolone dexamethasone intraocular suspension, 9%: single dose intracameral corticosteroid Prednisolone Acetate: topical ophthalmic drop for 3 weeks |
| FG001 | Postoperative Topical Prednisolone | postoperative topical prednisolone for 3 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
40 participants undergoing bilateral cataract surgery were enrolled; 40 eyes were in the intracameral dexamethasone group and 40 eyes were in the standard postoperative regimen group
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Post-operative Topical Prednisolone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 40 participants were enrolled, undergoing bilateral cataract surgery 40 eyes were in the intracameral dexamethasone group 40 eyes were in the standard postoperative regimen group |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | 95% Confidence Interval | mOsmol/L | 3 weeks | eyes | eyes |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intracameral Dexamethasone + Postoperative Prednisolone Acetate | intracameral dexamethasone 9% injection at the time of cataract surgery + standard postoperative prednisolone acetate regimen |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Sanjay Rao | SR Cornea Consultants | 8476685498 | sanjaynraomd@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 10, 2019 | Dec 9, 2020 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 9, 2019 | Nov 15, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| C009935 | prednisolone acetate |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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Randomized, controlled prospective study.
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| Prednisolone Acetate 1% Oph Susp | Drug | topical ophthalmic steroid drop |
|
topical ophthalmic prednisolone acetate Prednisolone Acetate: topical ophthalmic drop |
| BG002 | Total | Total of all reporting groups |
| eyes |
|
| Count of Units |
| eyes |
| eyes |
|
|
| Age, Continuous | Mean | Standard Deviation | years | eyes |
|
|
| Sex: Female, Male | Count of Units | eyes | eyes |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Region of Enrollment | 40 participants were enrolled, each eye of each participant received was assigned to a different treatment group | Number | eyes | eyes |
|
|
| Preoperative Tear Film Osmolarity | Mean | Full Range | mOsmo/L | eyes |
|
|
| Units | Counts |
|---|---|
| Participants |
|
| eyes |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | Postoperative Prednisolone Acetate Regimen | standard postoperative prednisolone acetate regimen | 0 | 40 | 0 | 40 | 0 | 40 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |