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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04247152
Recruitment Status : Completed
First Posted : January 29, 2020
Last Update Posted : April 20, 2020
Sponsor:
Information provided by (Responsible Party):
Research Insight LLC

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
Cataract Surgery Other: Intraoperative Aberrometry vs preoperative biometry Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : July 22, 2019
Actual Primary Completion Date : September 25, 2019
Actual Study Completion Date : September 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Proportion of Patients requiring Astigmatism Correction [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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?



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04247152


Locations
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United States, California
Harvard Eye Associates
Laguna Hills, California, United States, 92653
Sponsors and Collaborators
Research Insight LLC
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Responsible Party: Research Insight LLC
ClinicalTrials.gov Identifier: NCT04247152    
Other Study ID Numbers: 1909 ORA vs Biometry
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: April 20, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Cataract
Lens Diseases
Eye Diseases