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

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

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-10

Study Completion Date

2020-06-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Keratoconus Keratoconus Posterior

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Study group

Intracorneal ring segments are implanted for treatment of keratoconus, and posterior corneal surface is assessed preoperatively and postoperatively.

Group Type EXPERIMENTAL

Intracorneal ring segment implantation

Intervention Type PROCEDURE

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

Interventions

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Intracorneal 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

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No