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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

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.

Condition or disease Intervention/treatment Phase
Cataract Drug: Systane Complete Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact of Lubrication With Artificial Tears on Biometry Measurements for Cataract Surgery
Estimated Study Start Date : June 2020
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Tears

Arm Intervention/treatment
Experimental: Artificial Tears
One eye of each participant is randomized to receive Systane Complete artificial tears 4 times a day for 14 days
Drug: Systane Complete
1 drop 4 times a day for 14 days

No Intervention: No Artificial Tears
One eye of each participant is randomized to receive no artificial tears for 14 days



Primary Outcome Measures :
  1. 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

  2. Change in Baseline in Axis of Astigmatism [ Time Frame: Baseline, Day 14 ]
    The change in axis of astigmatism in all subjects


Secondary Outcome Measures :
  1. Change in Baseline Calculated Intraocular Lens Power [ Time Frame: Baseline, Day 14 ]
    The change in intraocular lens power calculation in all subjects

  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04230720


Locations
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United States, New York
Weill Cornell Ophthalmology
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Ashley Brissette, MD Weill Cornell Medicine
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT04230720    
Other Study ID Numbers: 19-11021101
First Posted: January 18, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Weill Medical College of Cornell University:
biometry measurement
artificial tear
cataract surgery
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases