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

Cataract Senile Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06165796
• Other study ID #: 004
• Status: Completed
• Start date: January 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: December 2023
• Source: Taipei Nobel Eye Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 331
• Est. completion date: December 1, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataract Senile

Intervention

Device:
• routine cataract surgery and intraocular lens implantation
routine cataract surgery and intraocular lens implantation

Locations

Country	Name	City	State
Taiwan	Taipei Nobel Eye Clinic	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Nobel Eye Clinic

Country where clinical trial is conducted

Taiwan, 

References & 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity		1 month after surgery
Primary	refractive prediction error		1 month after surgery