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Clinical Trials/NCT04230720
NCT04230720WithdrawnPhase 4

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

Weill Medical College of Cornell University1 site in 1 countryStarted: April 2021Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Withdrawn
Locations
1
Primary Endpoint
Change in Baseline in Axis of Astigmatism
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Artificial Tears

Experimental

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

Intervention: Systane Complete (Drug)

Outcomes

Primary Outcomes

Change in Baseline in Axis of Astigmatism

Time Frame: Baseline, Day 14

The change in axis of astigmatism in all subjects

Change in Baseline in Keratometry Values (K1 and K2)

Time Frame: Baseline, Day 14

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

Secondary Outcomes

  • Change in Keratometry Values (K1 and K2) in Ocular Surface Disease Subjects(Baseline, Day 14)
  • Change in Baseline Calculated Intraocular Lens Power(Baseline, Day 14)
  • Change in Axis of Astigmatism in Ocular Surface Disease Subjects(Baseline, Day 14)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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