Effect of Artificial Tears on Biometry

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04230720
• Other study ID #: 19-11021101
• Status: Withdrawn
• Phase: Phase 4
• Start date: April 2021
• Est. completion date: December 2021

Study information

• Verified date: June 2021
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Drug:
• Systane Complete
1 drop 4 times a day for 14 days

Locations

Country	Name	City	State
United States	Weill Cornell Ophthalmology	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Baseline in Keratometry Values (K1 and K2)	The change in keratometry (K) values (K1 and K2) in all subjects	Baseline, Day 14
Primary	Change in Baseline in Axis of Astigmatism	The change in axis of astigmatism in all subjects	Baseline, Day 14
Secondary	Change in Baseline Calculated Intraocular Lens Power	The change in intraocular lens power calculation in all subjects	Baseline, Day 14
Secondary	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	Baseline, Day 14
Secondary	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	Baseline, Day 14