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

Sponsor
Research Insight LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT04247152
Collaborator
(none)
200
1
1
2.1
93.7

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: Intraoperative Aberrometry vs preoperative biometry
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Comparison of Pre-operative Measurements With Intraoperative Aberrometry in Predicting Needed Correction for Low Toric Lens Correction in Cataract Surgery
Actual Study Start Date :
Jul 22, 2019
Actual Primary Completion Date :
Sep 25, 2019
Actual Study Completion Date :
Sep 25, 2019

Arms and Interventions

Arm Intervention/Treatment
Other: Intraoperative Aberrometry vs Preoperative Biometry

Retrospective view of existing chart data.

Other: Intraoperative Aberrometry vs preoperative biometry
Hypothesis: Intraoperative aberrometry measures lower levels of astigmatism more accurately than preoperative biometry in patients undergoing cataract surgery.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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?

  2. 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?

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Harvard Eye Associates Laguna Hills California United States 92653

Sponsors and Collaborators

  • Research Insight LLC

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Research Insight LLC
ClinicalTrials.gov Identifier:
NCT04247152
Other Study ID Numbers:
  • 1909 ORA vs Biometry
First Posted:
Jan 29, 2020
Last Update Posted:
Apr 20, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 20, 2020