Effect of Artificial Tears on Biometry

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04230720

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cataract	Drug: Systane Complete	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 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

Anticipated Study Start Date :

Apr 1, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Baseline in Keratometry Values (K1 and K2) [Baseline, Day 14]
The change in keratometry (K) values (K1 and K2) in all subjects
Change in Baseline in Axis of Astigmatism [Baseline, Day 14]
The change in axis of astigmatism in all subjects

Secondary Outcome Measures

Change in Baseline Calculated Intraocular Lens Power [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Ophthalmology	New York	New York	United States	10021

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT04230720

Other Study ID Numbers:

19-11021101

First Posted:

Jan 18, 2020

Last Update Posted:

Jun 22, 2021

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Weill Medical College of Cornell University

biometry measurement

artificial tear

cataract surgery

Additional relevant MeSH terms:

Cataract

Study Results

No Results Posted as of Jun 22, 2021