Back to resultsComparison of Pre-operative Measurements With Intraoperative Aberrometry in Predicting Correction for Low Toric Lens Correction in Cataract Surgery
Primary Purpose
Cataract Surgery
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intraoperative Aberrometry vs preoperative biometry
Sponsored by
About this trial
This is an interventional diagnostic trial for Cataract Surgery
Eligibility Criteria
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.
Sites / Locations
- Harvard Eye Associates
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Intraoperative Aberrometry vs Preoperative Biometry
Arm Description
Retrospective view of existing chart data.
Outcomes
Primary Outcome Measures
Proportion of Patients requiring Astigmatism Correction
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
Patients with Postoperative residual astigmatism 0.5 to 1.0 diopter
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
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?
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04247152
Brief Title
Comparison of Pre-operative Measurements With Intraoperative Aberrometry in Predicting Correction for Low Toric Lens Correction in Cataract Surgery
Official Title
Comparison of Pre-operative Measurements With Intraoperative Aberrometry in Predicting Needed Correction for Low Toric Lens Correction in Cataract Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
July 22, 2019 (Actual)
Primary Completion Date
September 25, 2019 (Actual)
Study Completion Date
September 25, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Research Insight LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Surgery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intraoperative Aberrometry vs Preoperative Biometry
Arm Type
Other
Arm Description
Retrospective view of existing chart data.
Intervention Type
Other
Intervention Name(s)
Intraoperative Aberrometry vs preoperative biometry
Intervention Description
Hypothesis: Intraoperative aberrometry measures lower levels of astigmatism more accurately than preoperative biometry in patients undergoing cataract surgery.
Primary Outcome Measure Information:
Title
Proportion of Patients requiring Astigmatism Correction
Description
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.
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
Patients with Postoperative residual astigmatism 0.5 to 1.0 diopter
Description
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?
Time Frame
up to 3 months
Title
Patients with Postoperative residual astigmatism 1.0 to 1.5 diopter
Description
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?
Time Frame
up to 3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Harvard Eye Associates
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Pre-operative Measurements With Intraoperative Aberrometry in Predicting Correction for Low Toric Lens Correction in Cataract Surgery
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