Effect of Artificial Tears on Biometry

NCT04230720 | Withdrawn Phase 4

• 1 other identifier: 19-11021101
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

biometry measurement; artificial tear; cataract surgery

Outcome Measures

Primary Outcomes (2)

• Change in Baseline in Keratometry Values (K1 and K2)

  The change in keratometry (K) values (K1 and K2) in all subjects

  Baseline, Day 14

• Change in Baseline in Axis of Astigmatism

  The change in axis of astigmatism in all subjects

  Baseline, Day 14

Secondary Outcomes (3)

• Change in Baseline Calculated Intraocular Lens Power

  Baseline, Day 14

• Change in Keratometry Values (K1 and K2) in Ocular Surface Disease Subjects

  Baseline, Day 14

• Change in Axis of Astigmatism in Ocular Surface Disease Subjects

  Baseline, Day 14

Study Arms (2)

Artificial Tears

EXPERIMENTAL

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

Drug: Systane Complete

No Artificial Tears

NO INTERVENTION

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

Interventions

Systane Complete DRUG

1 drop 4 times a day for 14 days

Artificial Tears

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Ophthalmology

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Ashley Brissette, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2020
• First Posted: January 18, 2020
• Study Start: April 1, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 22, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)