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

NCT ID: NCT06165796

Last Updated: 2023-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

331 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-01-01

Study Completion Date

2023-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cataract Senile

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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previous LASIK group

routine cataract surgery and intraocular lens implantation

Intervention Type DEVICE

routine cataract surgery and intraocular lens implantation

previous non-LASIK group

routine cataract surgery and intraocular lens implantation

Intervention Type DEVICE

routine cataract surgery and intraocular lens implantation

Interventions

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routine cataract surgery and intraocular lens implantation

routine cataract surgery and intraocular lens implantation

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Nobel Eye Clinic

OTHER

Sponsor Role lead

Responsible Party

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Chao-Kai Chang

Dean

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Taipei Nobel Eye Clinic

Taipei, , Taiwan

Site Status

Countries

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Taiwan

References

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Abulafia A, Hill WE, Koch DD, Wang L, Barrett GD. Accuracy of the Barrett True-K formula for intraocular lens power prediction after laser in situ keratomileusis or photorefractive keratectomy for myopia. J Cataract Refract Surg. 2016 Mar;42(3):363-9. doi: 10.1016/j.jcrs.2015.11.039. Epub 2016 Mar 19.

Reference Type BACKGROUND
PMID: 27006324 (View on PubMed)

Yeu E, Cuozzo S. Matching the Patient to the Intraocular Lens: Preoperative Considerations to Optimize Surgical Outcomes. Ophthalmology. 2021 Nov;128(11):e132-e141. doi: 10.1016/j.ophtha.2020.08.025. Epub 2020 Aug 31.

Reference Type RESULT
PMID: 32882308 (View on PubMed)

Other Identifiers

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004

Identifier Type: -

Identifier Source: org_study_id