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Simultaneous Corneal Wavefront-Guided Trans-PRK and Corneal Collagen Crosslinking After ICRS Implantation for Moderate Keratoconus

NCT ID: NCT03355430

Last Updated: 2017-11-28

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

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-07

Study Completion Date

2017-01-02

Brief Summary

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The investigators aim to investigate the effects of combined corneal wavefront-guided transepithelial photorefractive keratectomy (tPRK) and accelerated corneal collagen cross-linking (CXL) after intracorneal ring segment (ICRS) implantation in patients with moderate keratoconus. Medical records of 23 eyes of 23 patients undergoing combined tPRK and CXL after ICRS implantation were retrospectively analyzed. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction spherical equivalent (MRSE), corneal indices based on Scheimpflug tomography, higher-order aberrations (HOAs), and corneal biomechanical properties were evaluated before and after ICRS implantation, and at 1, 3, and 6 months after combined tPRK and CXL. Corneal biomechanical properties were measured using the dynamic Scheimpflug analyzer at approximately the same time of day.

Detailed Description

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The investigators aim to investigate the effects of combined corneal wavefront-guided transepithelial photorefractive keratectomy (tPRK) and accelerated corneal collagen cross-linking (CXL) after intracorneal ring segment (ICRS) implantation in patients with moderate keratoconus. Medical records of 23 eyes of 23 patients undergoing combined tPRK and CXL after ICRS implantation were retrospectively analyzed. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), manifest refraction spherical equivalent (MRSE), corneal indices based on Scheimpflug tomography, higher-order aberrations (HOAs), and corneal biomechanical properties were evaluated before and after ICRS implantation, and at 1, 3, and 6 months after combined tPRK and CXL. Corneal biomechanical properties were measured using the dynamic Scheimpflug analyzer at approximately the same time of day. The dynamic Scheimpflug analyzer automatically calculated corneal deformation amplitude, radius values, and maximal concave power when the cornea is deformed to its greatest curvature by the air puff. The deformation amplitude is defined as the maximum amplitude when the cornea is deformed to its greatest concave curvature and is influenced by corneal stiffness. The radius values represent the central concave curvature at the highest concavity (depressed to the highest concavity), while maximal concave power is the inverse radius of the curvature at the highest concavity.

Conditions

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Moderate Keratoconus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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moderate keratoconus group

moderate keratoconus group underwent combined corneal wavefront-guided transepithelial photorefractive keratectomy (tPRK) and accelerated corneal collagen cross-linking (CXL) after intracorneal ring segment (ICRS) implantation

combined corneal wavefront-guided transepithelial photorefractive keratectomy (tPRK)

Intervention Type PROCEDURE

After at least 1 month (average 2.7 ± 1.1 months; range 1 to 4 months), all patients were scheduled for combined corneal wavefront-guided tPRK and accelerated CXL treatment. tPRK between the corneal ring segments was performed using an excimer laser (Amaris 1050 Excimer Laser platform; Schwind eye-tech-solutions GmbH and Co KG, Kleinostheim, Germany).

accelerated corneal collagen cross-linking (CXL)

Intervention Type PROCEDURE

After at least 1 month (average 2.7 ± 1.1 months; range 1 to 4 months), all patients were scheduled for combined corneal wavefront-guided tPRK and accelerated CXL treatment. tPRK between the corneal ring segments was performed using an excimer laser (Amaris 1050 Excimer Laser platform; Schwind eye-tech-solutions GmbH and Co KG, Kleinostheim, Germany).

Interventions

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combined corneal wavefront-guided transepithelial photorefractive keratectomy (tPRK)

After at least 1 month (average 2.7 ± 1.1 months; range 1 to 4 months), all patients were scheduled for combined corneal wavefront-guided tPRK and accelerated CXL treatment. tPRK between the corneal ring segments was performed using an excimer laser (Amaris 1050 Excimer Laser platform; Schwind eye-tech-solutions GmbH and Co KG, Kleinostheim, Germany).

Intervention Type PROCEDURE

accelerated corneal collagen cross-linking (CXL)

After at least 1 month (average 2.7 ± 1.1 months; range 1 to 4 months), all patients were scheduled for combined corneal wavefront-guided tPRK and accelerated CXL treatment. tPRK between the corneal ring segments was performed using an excimer laser (Amaris 1050 Excimer Laser platform; Schwind eye-tech-solutions GmbH and Co KG, Kleinostheim, Germany).

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* intolerant to contact lenses
* moderate keratoconus without apical scarring
* if progression had been noted over the previous 6 months
* All included patients underwent combined corneal wavefront-guided tPRK and CXL at least 1 month (average 2.7 ± 1.1 months; range 1 to 4 months) after ICRS implantation.

Exclusion Criteria

* central or para-central corneal scarring
* central pachymetry \< 400 microns
* corneal endothelial cell density of less than 2000 cells/mm2
* systemic autoimmune disease
* a history of herpetic corneal disease
* pregnancy
* lactation
* severe dry eye syndrome
Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Ophthalmology, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Lee H, Kang DSY, Ha BJ, Choi JY, Kim EK, Seo KY, Kim TI. Visual rehabilitation in moderate keratoconus: combined corneal wavefront-guided transepithelial photorefractive keratectomy and high-fluence accelerated corneal collagen cross-linking after intracorneal ring segment implantation. BMC Ophthalmol. 2017 Dec 29;17(1):270. doi: 10.1186/s12886-017-0666-1.

Reference Type DERIVED
PMID: 29284455 (View on PubMed)

Other Identifiers

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4-2016-0403

Identifier Type: -

Identifier Source: org_study_id