Comparison of the Accuracy of Different Intraocular Lens Power Calculation Formulas in Cataract Patients With Prior Radial Keratotomy

April 3, 2024 updated by: He Eye Hospital
The Web-based Barret True K formula with no history formula has been proven to be a good choice for cataract patients after RK in several studies. The American society of cataract and refractive surgeons provides several IOL formulas for cataract patients who have undergone previous corneal refractive surgery. In cases where only IOL-Master data are available, Holladay 1 (Double-K) [Holladay 1 (D-K)] can be used for IOL power calculation in cataract patients with a history of RK. The traditional Haigis formula has also been shown to be effective for cataract patients after RK. To compare the accuracy of four intraocular lens (IOL) power calculation formulas in cataract patients after RK. They are Barrett True-K formula, Holladay 1(D-K) formula, Haigis formula, and MM formula.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Myopia is the most common cause of distance vision impairment. The prevalence of myopia has increased dramatically in the past few decades, especially in China. Corneal refractive surgery is an effective method to correct adult myopia. Radial keratotomy (RK) is one of the corneal refractive surgeries developed in the 1980s. Thirty years ago, many myopic patients underwent RK. As patients age, more and more patients have cataracts requiring cataract extraction and intraocular lens (IOL) implantation. The selection of appropriate and accurate IOL is an important factor to improve patient satisfaction. Recent studies have compared the accuracy of the newly developed IOL formula in patients with previous RK cataract. However, as a country with myopia and myopia surgery, there is no similar study in China. In addition, most patients with cataract after RK had lost ocular data before RK surgery. For RK patients without previous ocular data, how to accurately calculate the IOL power is still a clinical challenge.

Study Type

Observational

Enrollment (Estimated)

50

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with cataract after RK

Description

Inclusion Criteria:

  • Had a previous history of RK surgery
  • IOL-Master is available
  • There were no intraoperative and postoperative complications
  • Obvious refraction was performed 1 to 6 months after cataract surgery

Exclusion Criteria:

  • The investigator decided that it was not suitable for this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of the IOL formula
Time Frame: Baseline
To compare the accuracy of four intraocular lens (IOL) calculation formulas in cataract patients after radial keratotomy (RK). They are Barrett True-K formula, Holladay 1(D-K) formula, Haigis formula, and MM formula
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

He Eye Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2024

Primary Completion (Estimated)

August 15, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

April 3, 2024

First Submitted That Met QC Criteria

April 3, 2024

First Posted (Actual)

April 9, 2024

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 3, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAF2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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