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OpenTrials
Completed

NCT Number: NCT04748198

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

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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Key information

Conditions

Keratoconus Corneal Diseases Eye Diseases Keratoconus Posterior

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intracorneal ring segment implantation

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

Primary outcomes

  1. Posterior corneal astigmatism

    Time frame: Baseline to 12 months

    It is measured by corneal imaging device preoperatively and postoperatively

Secondary outcomes

  1. Visual Acuity

    Time frame: Baseline to 12 months

    It is measured by Snellen Chart Acuity

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Feb 10, 2021
Registry last updated
Feb 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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