NCT04342988

Effect of Cequa Treatment on Accuracy of Pre-operative Biometry & Higher Order Aberrations in Dry Eye Patients Undergoing Cataract Surgery

Effect of Cequa Treatment on Accuracy of Pre-operative Biometry and Higher Order Aberrations in Dry Eye Patients Undergoing Cataract Surgery

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Research Insight LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Dry Eye Syndromes

Interventions

Type	Name	Description
DRUG	Cequa	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.

Timeline

• Start date: 2020-04-08
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2020-04-13
• Last updated: 2021-03-12

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study