Comparison of Pre-operative Measurements With Intraoperative Aberrometry in Predicting Correction for Low Toric Lens Correction in Cataract Surgery

Not Applicable

Completed

• Conditions: Cataract Surgery
• Interventions: Other: Intraoperative Aberrometry vs preoperative biometry

• Registration Number: NCT04247152
• Lead Sponsor: Research Insight LLC

Brief Summary

Examination of the accuracy of toric predictive power in patients with 1.5 diopters of astigmatism or less.

Detailed Description

Based on preoperative keratometry and using the Baylor Nomogram and a standard factor for surgically-induced astigmatism, the investigators will calculate "keratometry-based total astigmatism" for each patient. This will be compared to "aberrometry-based total astigmatism", i.e. the total astigmatism measured by ORA in each case. With this information the investigators will determine in what portion of patients keratometry-based total astigmatism vs aberrometry-based total astigmatism predicts a need for astigmatism correction, (i.e., total astigmatism is greater than or equal to 0.5 D) during cataract surgery.

Study Timeline

• Study Start: 2019-07-22
• Primary Completion: 2019-09-25
• Study Completion: 2019-09-25
• Status Verified: 2020-01
• Study First Submitted: 2020-01-24
• Study First Submitted QC: 2020-01-27
• Study First Posted: 2020-01-29
• Last Update Submitted: 2020-04-16
• Last Update Posted: 2020-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients who underwent conventional (non-femtosecond) cataract surgery and whose "data to be collected" are accessible and available from the ORA database.
• Patients whose medical records show they did not exhibit any significant ocular morbidity that would be expected to influence outcome measures.

Exclusion Criteria

• Patients with visually significant co-morbidities (corneal, retina, optic nerve disease) that could affect their visual outcome or ability to be refracted after.
• Patients with surgical complications either during or after surgery (capsule tears, iris trauma, decentered IOL, cystoid macular edema, etc.)
• Patients with previous refractive surgery.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraoperative Aberrometry vs Preoperative Biometry	Intraoperative Aberrometry vs preoperative biometry	Retrospective view of existing chart data.

Primary Outcome Measures

Name	Time	Method
Proportion of Patients requiring Astigmatism Correction	up to 3 months	Proportion of patients requiring astigmatism correction, i.e., having need for astigmatism correction of greater than or equal to 0.5 D during cataract surgery, when measured by preoperative keratometry vs intraoperative aberrometry.

Secondary Outcome Measures

Name	Time	Method
Patients with Postoperative residual astigmatism 0.5 to 1.0 diopter	up to 3 months	Looking at patients whose ORA-based total astigmatism was greater than or equal to 0.5 and less than or equal to 1.0 diopter, did patients receiving astigmatism correction have less postoperative residual astigmatism than those who did not receive astigmatism correction?
Patients with Postoperative residual astigmatism 1.0 to 1.5 diopter	up to 3 months	Looking at patients whose ORA-based total astigmatism was greater than 1.0 and less than or equal to 1.5 diopter,m did patients receiving astigmatism correction have less postoperative residual astigmatism than those who did not receive astigmatism correction?

Trial Locations

Locations (1)

Harvard Eye Associates; 🇺🇸 Laguna Hills, California, United States