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

NCT06165796 | Completed

• 1 other identifier: 004
• Study Type: observational
• Target: 331
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cataract Senile

Outcome Measures

Primary Outcomes (2)

• visual acuity

  1 month after surgery

• refractive prediction error

  1 month after surgery

Study Arms (2)

previous LASIK group

Device: routine cataract surgery and intraocular lens implantation

previous non-LASIK group

Device: routine cataract surgery and intraocular lens implantation

Interventions

routine cataract surgery and intraocular lens implantation DEVICE

routine cataract surgery and intraocular lens implantation

previous LASIK group; previous non-LASIK group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Nobel Eye Clinic: lead

Study Sites (1)

Taipei Nobel Eye Clinic

Taipei, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 27006324 BACKGROUND

• 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.

  PMID: 32882308 RESULT

MeSH Terms

Interventions

Lens Implantation, Intraocular

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean

Study Record Dates

• First Submitted: December 4, 2023
• First Posted: December 11, 2023
• Study Start: January 1, 2022
• Primary Completion: November 30, 2023
• Study Completion: December 1, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)