Effect of Artificial Tears on Biometry

Study Overview
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Brief Summary
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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.

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

Conditions
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Cataract

Intervention / Treatment
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* Drug: Systane Complete


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artificial Tears<br>One eye of each participant is randomized to receive Systane Complete artificial tears 4 times a day for 14 days | Drug: Systane Complete<br>* 1 drop 4 times a day for 14 days<br>|
| No Intervention: No Artificial Tears<br>One eye of each participant is randomized to receive no artificial tears for 14 days | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Baseline Calculated Intraocular Lens Power | The change in intraocular lens power calculation in all subjects | Baseline, Day 14 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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biometry measurement, artificial tear, cataract surgery