Effect of Artificial Tears on Biometry

Phase 4

Withdrawn

• Conditions: Cataract
• Interventions: Drug: Systane Complete

• Registration Number: NCT04230720
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-14
• Study First Posted: 2020-01-18
• Study Start: 2021-04
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-16
• Last Update Posted: 2021-06-22
• Primary Completion: 2021-12
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 Baseline Calculated Intraocular Lens Power	Baseline, Day 14	The change in intraocular lens power calculation in all subjects
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

Trial Locations

Locations (1)

Weill Cornell Ophthalmology; 🇺🇸 New York, New York, United States