The Effect of LASIK on the Calibration of IOL Formula Calculation: a Comparative Study

December 4, 2023 updated by: Chao-Kai Chang, Taipei Nobel Eye Clinic
Direct comparison study between previous LASIK or non-LASIK cataract eyes, the performance between non-LASIK and LASIK patients were (i) Ophthalmic examinations: UDVA, CDVA and uncorrected near visual acuity (UNVA) (40cm) and (ii) Refractive prediction error: defined as difference between postoperative sphere and target refraction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

331

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Taipei Nobel Eye Clinic

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

Non-Probability Sample

Study Population

Clear corneal phacoemulsification and IOL implantation were performed by single surgeon Chao-Kai Chang. The surgical process involved topical anesthesia, a 3-step clear corneal incision (2.75 mm) at 180° (temporal in both eyes), a 5.0-mm continuous curvilinear capsulorhexis, phacoemulsification using the stop-and-chop technique, IOL implantation with an injector, IOL centration, and a sutureless incision. The study IOL models include only EDOF Symfony IOL (Johnson and Johnson, Santa Ana, CA, USA).

Description

Inclusion Criteria:

  • presence of cataract in both eyes
  • corrected distance visual acuity under 20/40
  • Phacoemulsification cataract surgery was arranged for both eyes

Exclusion Criteria:

  • complicated cataract
  • corneal opacities or irregularities
  • corneal astigmatism > 1.50 diopter
  • amblyopia, anisometropia
  • surgical complications such as posterior capsular bag rupture or vitreous loss, IOL tilt or decentration
  • coexisting ocular pathologies, glaucoma, non-dilating pupil, history of intraocular surgery, or retinopathy
  • optic nerve or macular diseases
  • refusal or unable to maintain follow-up.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
previous LASIK group
Device: routine cataract surgery and intraocular lens implantation
routine cataract surgery and intraocular lens implantation
previous non-LASIK group
Device: routine cataract surgery and intraocular lens implantation
routine cataract surgery and intraocular lens implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
visual acuity
Time Frame: 1 month after surgery
1 month after surgery
refractive prediction error
Time Frame: 1 month after surgery
1 month after surgery

Collaborators and Investigators

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

Sponsor

Taipei Nobel Eye Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 1, 2022

Primary Completion (Actual)

November 30, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

December 4, 2023

First Submitted That Met QC Criteria

December 4, 2023

First Posted (Estimated)

December 11, 2023

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 4, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 004

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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