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Effect of Artificial Tears on Biometry

Primary Purpose

Cataract

Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Systane Complete
Sponsored by
Weill Medical College of Cornell University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring biometry measurement, artificial tear, cataract surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Weill Cornell Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Artificial Tears

No Artificial Tears

Arm Description

One eye of each participant is randomized to receive Systane Complete artificial tears 4 times a day for 14 days

One eye of each participant is randomized to receive no artificial tears for 14 days

Outcomes

Primary Outcome Measures

Change in Baseline in Keratometry Values (K1 and K2)
The change in keratometry (K) values (K1 and K2) in all subjects
Change in Baseline in Axis of Astigmatism
The change in axis of astigmatism in all subjects

Secondary Outcome Measures

Change in Baseline Calculated Intraocular Lens Power
The change in intraocular lens power calculation in all subjects
Change in Keratometry Values (K1 and K2) in Ocular Surface Disease Subjects
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
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

Full Information

First Posted
January 14, 2020
Last Updated
June 16, 2021
Sponsor
Weill Medical College of Cornell University
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1. Study Identification

Unique Protocol Identification Number
NCT04230720
Brief Title
Effect of Artificial Tears on Biometry
Official Title
Impact of Lubrication With Artificial Tears on Biometry Measurements for Cataract Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Withdrawn
Why Stopped
Stopped due to COVID-19.
Study Start Date
April 2021 (Anticipated)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract
Keywords
biometry measurement, artificial tear, cataract surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Artificial Tears
Arm Type
Experimental
Arm Description
One eye of each participant is randomized to receive Systane Complete artificial tears 4 times a day for 14 days
Arm Title
No Artificial Tears
Arm Type
No Intervention
Arm Description
One eye of each participant is randomized to receive no artificial tears for 14 days
Intervention Type
Drug
Intervention Name(s)
Systane Complete
Intervention Description
1 drop 4 times a day for 14 days
Primary Outcome Measure Information:
Title
Change in Baseline in Keratometry Values (K1 and K2)
Description
The change in keratometry (K) values (K1 and K2) in all subjects
Time Frame
Baseline, Day 14
Title
Change in Baseline in Axis of Astigmatism
Description
The change in axis of astigmatism in all subjects
Time Frame
Baseline, Day 14
Secondary Outcome Measure Information:
Title
Change in Baseline Calculated Intraocular Lens Power
Description
The change in intraocular lens power calculation in all subjects
Time Frame
Baseline, Day 14
Title
Change in Keratometry Values (K1 and K2) in Ocular Surface Disease Subjects
Description
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
Time Frame
Baseline, Day 14
Title
Change in Axis of Astigmatism in Ocular Surface Disease Subjects
Description
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
Time Frame
Baseline, Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashley Brissette, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Ophthalmology
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Effect of Artificial Tears on Biometry

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