Comparison of Anterior Corneal Optical Aberration Induced by CK and Hyperopic LASIK

NCT04676620 | Unknown DMC

• 1 other identifier: 2020-K-107
• Study Type: observational
• Target: 69
• Locations: 1 country
• Sites: 1

Brief Summary

Conductive keratoplasty (CK) had shown to be a safe and effective procedure for the treatment of low to moderate hypeopia. It had been approved by the U.S. Food and Drug Administration (FDA) to treat presbyope in early 2004. CK appeals to both surgeons and patients as it avoids the need for flap creation, the use of high intraocular pressure (IOP), or tissue ablation. It utilizes "blended vision" rather than the true monovision used with laser in situ keratomileusis (LASIK), which patients tolerate more readily. There is very little reported research about the induction of wavefront aberration by CK. The symptomatology of high order aberrations (HOA) and the way individual Zernike functions were correlated with visual acuity, contrast sensitivity, visual symptoms. This study measured the HOA created by surgically induced myopic shift via CK and LASIK in an effort to better understand the phenomena of regression, multifocality, pseudo-accommodation and monovision.

Conditions

Refractive Error

Keywords

conductive keratoplasty; corneal optical aberrations; hyperopic corrections; LASIK

Outcome Measures

Primary Outcomes (2)

• uncorrected visual acuity

  uncorrected visual acuity change from baseline at 6 months

  change from baseline with EDTRS chart at 6 months

• best spectacle-corrected visual acuity

  best spectacle-corrected visual acuity change from baseline with EDTRS chart at 6 months

  change from baseline with EDTRS chart at 6 months

Secondary Outcomes (2)

• near vision

  change from baseline with EDTRS chart at 6 months

• central and peripheral corneal ultrasound pachymetry

  change from baseline with EDTRS chart at 6 months

Study Arms (2)

CK surgery

Conductive keratoplasty (CK) had shown to be a safe and effective procedure for the treatment of low to moderate hypeopia. It had been approved by the U.S. Food and Drug Administration (FDA) to treat presbyope in early 2004. CK appeals to both surgeons and patients as it avoids the need for flap creation, the use of high intraocular pressure (IOP), or tissue ablation.

Procedure: CK surgery

LASIK surgery

LASIK surgery is femtosecond laser assisted conventional refractive surgery and has also been proved to offer many advantages in terms of visual acuity, corneal sensitivity, and corneal biomechanics compared with traditional refractive surgeries.

Procedure: CK surgery

Interventions

CK surgery PROCEDURE

CK and LASIK are both effective methods for the correction of hypeopia. They have been proved to offer many advantages in terms of visual acuity, corneal sensitivity, and corneal biomechanics compared with traditional refractive surgeries.

CK surgery; LASIK surgery

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In this consecutive case series, 69 eyes of 57 patients (30 female and 27 male) with hyperopia or presbyopia were enrolled. Inclusion criteria included age of over 40 years old (yrs), stable refraction, and patients who were planned to induce a myopic shift ranging of -1.00 diopters (D) to -2.50D. Mean patient age was 52.9±5.7 yrs (range from 42 to 68 yrs). The ophthalmic examination for each patient included uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA) (Snellen chart), near vision (Jaeger chart), manifest and cycloplegic refraction, videokeratography, central and peripheral corneal ultrasound pachymetry (thickness), slit-lamp microscopy, dilated fundus examinations, IOP.

You may qualify if:

• age of over 40 years old (yrs)
• stable refraction
• planned to induce a myopic shift

You may not qualify if:

• age of less than 40 years old (yrs)
• significant systemic illnesses
• congenital myopia,
• media opacity uveitis
• glaucoma
• intraocular surgery refractive surgery
• neurologic diseases
• retinal disease

Sponsors & Collaborators

• Wang Hongxia: lead
• Tianjin Eye Hospital: collaborator

Study Sites (1)

Shanghai Guanghua Integrated Traditional Chinese and Western Medicine Hospital

Shanghai, Shanghai Municipality, 200052, China

RECRUITING

Related Publications (3)

• Du TT, Fan VC, Asbell PA. Conductive keratoplasty. Curr Opin Ophthalmol. 2007 Jul;18(4):334-7. doi: 10.1097/ICU.0b013e3281df2cf0.

  PMID: 17568211 RESULT

• Lin DY, Manche EE. Two-year results of conductive keratoplasty for the correction of low to moderate hyperopia. J Cataract Refract Surg. 2003 Dec;29(12):2339-50. doi: 10.1016/j.jcrs.2003.09.022.

  PMID: 14709295 RESULT

• Pallikaris lG, Naoumidi TL, Panagopoulou SI, Alegakis AK, Astyrakakis NI. Conductive keratoplasty for low to moderate hyperopia: 1-year results. J Refract Surg. 2003 Sep-Oct;19(5):496-506. doi: 10.3928/1081-597X-20030901-04.

  PMID: 14518738 RESULT

MeSH Terms

Conditions

Refractive Errors

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Hongxia Wang, director

  Shanghai Guanghua integrated traditional Chinese and Western Medicine Hospital

  STUDY DIRECTOR

Central Study Contacts

Hongxia Wang, director

CONTACT

18302183233; whxeye@163.com

Qian Fan, professor

CONTACT

15022756478; fanqian2002_yahoo@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: December 21, 2020
• Study Start: December 1, 2020
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)