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Effect of Intraoperative Dexamethasone on Post-op Dry Eye

Sponsor
SR Cornea Consultants (Other)
Overall Status
Completed
CT.gov ID
NCT04184999
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
3.7
Actual Duration (Months)
10.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: dexamethasone intraocular suspension, 9%
  • Drug: Prednisolone Acetate 1% Oph Susp
 Phase 4

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized, controlled prospective study.Randomized, controlled prospective study.
Masking:
Single (Participant)
Primary Purpose:
Prevention
Official Title:
Evaluation of Intraoperative Use of Dexycu on the Signs and Symptoms of Dry Eye
Actual Study Start Date :
Aug 10, 2019
Actual Primary Completion Date :
Dec 1, 2019
Actual Study Completion Date :
Dec 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intracameral dexamethasone 9% + postoperative topical prednisolone acetate

dexamethasone intraocular suspension, 9% injected intracamerally at the time of cataract surgery + topical ophthalmic prednisolone acetate for 3 weeks post-operatively

Drug: dexamethasone intraocular suspension, 9%
single dose intracameral corticosteroid
Other Names:
  • Dexycu

    • Drug: Prednisolone Acetate 1% Oph Susp
    topical ophthalmic steroid drop
    Active Comparator: postoperative topical prednisolone acetate

    topical ophthalmic prednisolone acetate for 3 weeks post-operatively

    Drug: Prednisolone Acetate 1% Oph Susp
    topical ophthalmic steroid drop

    Outcome Measures

    Primary Outcome Measures

    1. 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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hauser Ross Surgical Center Sycamore Illinois United States 60178

    Sponsors and Collaborators

    • SR Cornea Consultants

    Investigators

    • Principal Investigator: Sanjay Rao, MD, SR Cornea Conslutants

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Sanjay N Rao, MD, Principal Investigator, SR Cornea Consultants
    ClinicalTrials.gov Identifier:
    NCT04184999
    Other Study ID Numbers:
    • SRCC10
    First Posted:
    Dec 4, 2019
    Last Update Posted:
    Feb 16, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Dexamethasone
    Prednisolone
    Methylprednisolone Acetate
    Methylprednisolone
    Methylprednisolone Hemisuccinate
    Prednisolone acetate
    Prednisolone hemisuccinate
    Prednisolone phosphate

    Study Results

    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 Detail 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
    Arm/Group Title Intracameral Dexamethasone + Postoperative Topical Prednisolone Postoperative Topical Prednisolone
    Arm/Group Description dexamethasone intraocular suspension, 9% + topical ophthalmic prednisolone dexamethasone intraocular suspension, 9%: single dose intracameral corticosteroid Prednisolone Acetate: topical ophthalmic drop for 3 weeks postoperative topical prednisolone for 3 weeks
    Period Title: Overall Study
    STARTED 40 40
    3 Week Tear Film Osmolarity Testing 40 40
    COMPLETED 40 40
    NOT COMPLETED 0 0

    Baseline Characteristics

    Arm/Group Title Intracameral Dexamethasone + Post-operative Topical Prednisolone Post-operative Topical Prednisolone Total
    Arm/Group Description dexamethasone intraocular suspension, 9% + topical ophthalmic prednisolone dexamethasone intraocular suspension, 9%: single dose intracameral corticosteroid Prednisolone Acetate: topical ophthalmic drop topical ophthalmic prednisolone acetate Prednisolone Acetate: topical ophthalmic drop Total of all reporting groups
    Overall Participants 40 40 40
    Overall eyes 40 40 80
    Age (eyes) [Count of Units]
    <=18 years
    1
    1
    2
    Between 18 and 65 years
    15
    15
    30
    >=65 years
    24
    24
    48
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    67.49
    (10.42)
    67.49
    (10.42)
    67.49
    (10.42)
    Sex: Female, Male (eyes) [Count of Units]
    Female
    22
    22
    44
    Male
    18
    18
    36
    Race and Ethnicity Not Collected (Count of Participants)
    Count of Participants [Participants]
    0
    0%
    Region of Enrollment (eyes) [Number]
    United States
    40
    40
    80
    Preoperative Tear Film Osmolarity (mOsmo/L) [Mean (Full Range) ]
    Mean (Full Range) [mOsmo/L]
    307.475
    307.775
    307.625

    Outcome Measures

    1. Primary Outcome
    Title Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively
    Description 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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Intracameral Dexamethasone Postoperative Prednisolone Acetate
    Arm/Group Description intracameral dexamethasone + postoperative prednisolone acetate for 3 weeks postoperative prednisolone acetate for 3 weeks
    Measure Participants 40 40
    Measure eyes 40 40
    Mean (95% Confidence Interval) [mOsmol/L]
    311.15
    316.3
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Intracameral Dexamethasone
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <.01
    Comments
    Method ANOVA
    Comments
    Method of Estimation Estimation Parameter F-Statistic
    Estimated Value 207.4
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments

    Adverse Events

    Time Frame 3 months
    Adverse Event Reporting Description
    Arm/Group Title Intracameral Dexamethasone + Postoperative Prednisolone Acetate Postoperative Prednisolone Acetate Regimen
    Arm/Group Description intracameral dexamethasone 9% injection at the time of cataract surgery + standard postoperative prednisolone acetate regimen standard postoperative prednisolone acetate regimen
    All Cause Mortality
    Intracameral Dexamethasone + Postoperative Prednisolone Acetate Postoperative Prednisolone Acetate Regimen
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/40 (0%) 0/40 (0%)
    Serious Adverse Events
    Intracameral Dexamethasone + Postoperative Prednisolone Acetate Postoperative Prednisolone Acetate Regimen
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/40 (0%) 0/40 (0%)
    Other (Not Including Serious) Adverse Events
    Intracameral Dexamethasone + Postoperative Prednisolone Acetate Postoperative Prednisolone Acetate Regimen
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/40 (0%) 0/40 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Sanjay Rao
    Organization SR Cornea Consultants
    Phone 8476685498
    Email sanjaynraomd@gmail.com
    Responsible Party:
    Sanjay N Rao, MD, Principal Investigator, SR Cornea Consultants
    ClinicalTrials.gov Identifier:
    NCT04184999
    Other Study ID Numbers:
    • SRCC10
    First Posted:
    Dec 4, 2019
    Last Update Posted:
    Feb 16, 2021
    Last Verified:
    Jan 1, 2021