Effect of Artificial Tears on Biometry

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

Status

Withdrawn

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04230720

Enrollment

Registered

2020-01-18

Start date

2021-04-30

Completion date

2021-12-31

Last updated

2021-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract

Keywords

biometry measurement, artificial tear, cataract surgery

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.

Interventions

DRUGSystane Complete

1 drop 4 times a day for 14 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026