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

A

Ain Shams University

Status

Completed

Conditions

Keratoconus
Keratoconus Posterior

Treatments

Procedure: Intracorneal ring segment implantation

Study type

Interventional

Funder types

Other

Identifiers

NCT04748198
FMASU MD 140/2018

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 patients

Sex

All

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

60 participants in 1 patient group

Study group
Experimental group
Description:
Intracorneal ring segments are implanted for treatment of keratoconus, and posterior corneal surface is assessed preoperatively and postoperatively.
Treatment:
Procedure: Intracorneal ring segment implantation

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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