Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Artificial Tears on Biometry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04230720
Recruitment Status : Suspended (Temporarily paused due to COVID-19 and will resume based on guidance of public health authorities. This is not a suspension of IRB approval.)
First Posted : January 18, 2020
Last Update Posted : May 28, 2020
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Tracking Information
First Submitted Date  ICMJE January 14, 2020
First Posted Date  ICMJE January 18, 2020
Last Update Posted Date May 28, 2020
Estimated Study Start Date  ICMJE June 2020
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2020)
  • Change in Baseline in Keratometry Values (K1 and K2) [ Time Frame: Baseline, Day 14 ]
    The change in keratometry (K) values (K1 and K2) in all subjects
  • Change in Baseline in Axis of Astigmatism [ Time Frame: Baseline, Day 14 ]
    The change in axis of astigmatism in all subjects
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2020)
  • Change in Baseline Calculated Intraocular Lens Power [ Time Frame: Baseline, Day 14 ]
    The change in intraocular lens power calculation in all subjects
  • Change in Keratometry Values (K1 and K2) in Ocular Surface Disease Subjects [ Time Frame: Baseline, Day 14 ]
    The change in keratometry (K) values (K1 and K2) in a subset of subjects that were positive for ocular surface disease on the American Society of Cataract and Refractive Surgery (ASCRS) modified Standardized Patient Evaluation of Eye Dryness (SPEED2) questionnaire
  • Change in Axis of Astigmatism in Ocular Surface Disease Subjects [ Time Frame: Baseline, Day 14 ]
    The change in axis of corneal astigmatism in a subset of subjects that were positive for ocular surface disease on the American Society of Cataract and Refractive Surgery (ASCRS) modified Standardized Patient Evaluation of Eye Dryness (SPEED2) questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Artificial Tears on Biometry
Official Title  ICMJE Impact of Lubrication With Artificial Tears on Biometry Measurements for Cataract Surgery
Brief Summary The purpose of this study is to determine if measurements for cataract surgery are improved with use of additional lubrication with artificial tears. The research study is being done to optimize measurements and provide patients with the best visual outcomes after cataract surgery.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cataract
Intervention  ICMJE Drug: Systane Complete
1 drop 4 times a day for 14 days
Study Arms  ICMJE
  • Experimental: Artificial Tears
    One eye of each participant is randomized to receive Systane Complete artificial tears 4 times a day for 14 days
    Intervention: Drug: Systane Complete
  • No Intervention: No Artificial Tears
    One eye of each participant is randomized to receive no artificial tears for 14 days
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: January 14, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2021
Estimated Primary Completion Date January 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female ≥ 18 years of age
  • Documentation of bilateral age-related senile cataracts diagnosis

Exclusion Criteria:

  • Patients currently using regularly scheduled artificial tears. Patients with infrequent or irregular use of artificial tears may not be excluded from the study.
  • Patients using contact lenses.
  • Patients with any other surface pathology affecting corneal biometric measurements determined with slit-lamp examination or medical history.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04230720
Other Study ID Numbers  ICMJE 19-11021101
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Weill Medical College of Cornell University
Study Sponsor  ICMJE Weill Medical College of Cornell University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ashley Brissette, MD Weill Cornell Medicine
PRS Account Weill Medical College of Cornell University
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP