Effect of Artificial Tears on Biometry

June 16, 2021 updated by: Weill Medical College of Cornell University

Impact of Lubrication With Artificial Tears on Biometry Measurements for Cataract Surgery

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, Day 14
Change in Baseline in Axis of Astigmatism
Time Frame: Baseline, Day 14
The change in axis of astigmatism in all subjects
Baseline, Day 14

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Baseline Calculated Intraocular Lens Power
Time Frame: Baseline, Day 14
The change in intraocular lens power calculation in all subjects
Baseline, Day 14
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
Baseline, Day 14
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
Baseline, Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Ashley Brissette, MD, Weill Medical College of Cornell University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

December 1, 2021

Study Registration Dates

First Submitted

January 14, 2020

First Submitted That Met QC Criteria

January 14, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

June 22, 2021

Last Update Submitted That Met QC Criteria

June 16, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-11021101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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