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Completed

NCT Number: NCT04247152

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

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

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Key information

Conditions

Cataract Surgery

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Harvard Eye Associates

Laguna Hills, California, 92653, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intraoperative Aberrometry vs preoperative biometry

Other

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

Primary outcomes

  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 outcomes

  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?

Sponsors and collaborators

Lead sponsor

Research Insight LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 29, 2020
Registry last updated
Apr 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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