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Effect of Intracorneal Ring Segments on Posterior Corneal Tomography in Eyes With Keratoconus

Effect of Intracorneal Ring Segments on Posterior Corneal Tomography in Eyes With Keratoconus

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04748198
Enrollment
60
Registered
2021-02-10
Start date
2018-06-10
Completion date
2020-06-15
Last updated
2021-02-10

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

Conditions

Keratoconus, Keratoconus Posterior

Keywords

keratoconus, intracorneal ring segments, posterior corneal surface

Brief summary

Our purpose is to analyze the changes induced in the posterior corneal surface in patients implanted with intracorneal ring segments for treatment of keratoconus. Patients are assessed with corneal imaging device preoperatively and at 1, 3, 6 and 12 months postoperatively.

Detailed description

Procedure: Femtosecond laser assisted implantation of intracorneal ring segments in keratoconus patients Uncorrected visual acuity (UCVA), best corrected visual acuity (BCVA), refraction, keratometric (K) readings of the anterior and posterior surface, corneal asphericity (Q value) of the anterior and posterior surface, and anterior and posterior elevations are evaluated using a corneal imaging device preoperatively and at 1, 3, 6 and 12 months after surgery.

Interventions

PROCEDUREIntracorneal ring segment implantation

Surgical procedure for keratoconus treatment. A tunnel is created in the corneal stroma with femtosecond laser and ring segments are implanted in the corneal stroma

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Patients with keratoconus grade 1, 2 or 3 according to Amsler-Krumeich classification. * Best corrected visual acuity (BCVA) ≤ 6/12. * Mean front keratometric (K) readings ≤ 60 diopters (D). * Corneal thickness ≥ 400 µm at the location of ICRS implantation. * Clear central cornea

Exclusion criteria

* Central corneal opacity. * Previous corneal laser refractive surgery. * Previous corneal collagen cross linking. * Previous cataract surgery or phakic IOL implantation. * History of herpetic keratitis. * History of acute hydrops. * Ocular comorbidities such as cataract, glaucoma or retinal disease. * Systemic diseases affecting healing process such as autoimmune or connective tissue disease.

Design outcomes

Primary

MeasureTime frameDescription
Posterior corneal astigmatismBaseline to 12 monthsIt is measured by corneal imaging device preoperatively and postoperatively

Secondary

MeasureTime frameDescription
Visual AcuityBaseline to 12 monthsIt is measured by Snellen Chart Acuity

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026