Cequa
DrugThe effect of Cequa treatment on the accuracy of pre-operative biometry and on corneal higher-order aberrations (HOAs) in cataract patients who have signs of dry eye disease.
NCT Number: NCT04342988
The purpose of this study is to examine the effect of Cequa treatment on the accuracy of pre-operative biometry and on corneal higher-order aberrations (HOAs) in cataract patients who have signs of dry eye disease.
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Notify Me18 year and older
All sexes
Interventional
Phase 4
Harvard Eye Associates, Laguna Hills, California, United States
Hypothesis: In patients with dry eye, defined as corneal staining and a reduced tear breakup time, the accuracy of pre-operative biometry and corneal surface HOAs will improve significantly after four weeks of Cequa treatment.
Primary Outcome Measure: Spherical equivalent prediction error of pre-Cequa vs post-Cequa ocular biometry performed for cataract surgery.
Secondary Outcome Measures:
The impact of Cequa treatment on corneal higher order aberrations measured in the central 6 mm of the cornea.
The difference in SPEED questionnaire scores before and 4 weeks after Cequa treatment.
The difference in corneal staining and tear breakup time (TBUT) before and after treatment with Cequa.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The effect of Cequa treatment on the accuracy of pre-operative biometry and on corneal higher-order aberrations (HOAs) in cataract patients who have signs of dry eye disease.
Time frame: Four weeks
Time frame: Four Weeks
Time frame: Four Weeks
To compare the difference in Standard Patient of Eye Dryness Questionnaire (SPEED) scores before and after 4 weeks of therapy with Cequa BID among patients with significant dry eye (decreased TBUT or corneal staining) with planned cataract surgery. The SPEED questionnaire gives a score from 0-28 that is the result of 8 items that assess frequency and severity of symptoms. Speed Score Severity rating: 0-4 Mild, 5-7 Moderate, 8+ Severe.
Time frame: Four Weeks
The presence of central or inferior corneal fluorescein staining defined by the Oxford Scale.
Time frame: Four Weeks
Reduced tear break up time (TBUT) ≤ 10 seconds.
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Industry
Effect of Cequa Treatment on Accuracy of Pre-operative Biometry and Higher Order Aberrations in Dry Eye Patients Undergoing Cataract Surgery
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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