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

NCT ID: NCT04676620

Last Updated: 2020-12-21

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

UNKNOWN

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-31

Study Completion Date

2021-12-31

Brief Summary

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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.

Detailed Description

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To investigate anterior corneal optical higher order aberration (HOA) induced by conductive keratoplasty (CK) and laser in situ keratomileusis (LASIK). 69 eyes with hyperopia or presbyopia were enrolled. 47 eyes of 47 patients underwent CK procedure, 22 eyes underwent LASIK. Data were acquired preoperatively, and at 3 and 6 months postoperatively. The total Root Mean Square (RMS) of the HOA as well as the individual Zernike polynomials of coma, trefoil, and spherical aberration were analyzed. In CK group, the high order RMS showed significant elevation at 3 months, but it returned to near preoperative levels at 6 months postoperatively. Trefoil (Z33) is the exclusive Zenike pattern to increase significantly following CK, peaking at 3 months and then decreasing back to near preoperative level at 6 months after CK. In the hyperopic LASIK group, coma increased to a peak at 3 month postoperatively, and persisted at sixth month after LASIK. Spherical aberration decreased significantly at 3 months and persisted till the sixth postoperative month. There was significant correlation between ΔSE and Δspherical aberration showed in both groups. The HOA and main Zernike polynomials pattern and their natural changes induced by CK is significantly different from that induced by LASIK in the hyperopic corrected treatment. The amount of achieved hyperopic corrections induced by CK or LASIK is not correlated to the change of HOA patterns such as coma and trefoil, but it is correlated to the change of spherical aberration.

Conditions

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Refractive Error

Keywords

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conductive keratoplasty corneal optical aberrations hyperopic corrections LASIK

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

CK surgery

Intervention Type 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.

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.

CK surgery

Intervention Type 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.

Interventions

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CK surgery

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Eye Hospital

OTHER

Sponsor Role collaborator

Wang Hongxia

OTHER

Sponsor Role lead

Responsible Party

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Wang Hongxia

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hongxia Wang, director

Role: STUDY_DIRECTOR

Shanghai Guanghua integrated traditional Chinese and Western Medicine Hospital

Locations

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Shanghai Guanghua Integrated Traditional Chinese and Western Medicine Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongxia Wang, director

Role: CONTACT

Phone: 18302183233

Email: [email protected]

Qian Fan, professor

Role: CONTACT

Phone: 15022756478

Email: [email protected]

Facility Contacts

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Hongxia Wang, director

Role: primary

References

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

Reference Type RESULT
PMID: 17568211 (View on PubMed)

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.

Reference Type RESULT
PMID: 14709295 (View on PubMed)

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.

Reference Type RESULT
PMID: 14518738 (View on PubMed)

Other Identifiers

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2020-K-107

Identifier Type: -

Identifier Source: org_study_id