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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03355430
Enrollment
23
Registered
2017-11-28
Start date
2016-07-07
Completion date
2017-01-02
Last updated
2017-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Moderate Keratoconus

Brief summary

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

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.

Interventions

PROCEDUREcombined 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).

PROCEDUREaccelerated 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).

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
visual acuityPre-operation (baseline)visual acuity in eyes undergoing combined corneal wavefront-guided transepithelial photorefractive keratectomy and accelerated corneal collagen cross-linking after intracorneal ring segment implantation in patients with moderate keratoconus

Secondary

MeasureTime frameDescription
Corneal indicesPre-operation (baseline)Multiple corneal indices were measured at the 8-mm zone using the Scheimpflug tomography system (Pentacam HR; OCULUS).

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026