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Completed

NCT Number: NCT06498570

Clinical Outcomes of Two Symmetrical Kera-rings Implantation in Grade Three Keratoconus

Clinical Outcomes of Two Symmetrical Kera-rings Implantation in Grade Three Keratoconus

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Key information

Conditions

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Elshimaa A.Mateen

Sohag, Egypt

About this study

a retrospective non- randomized controlled clinical study. The study included twenty-three grade 3 keratoconic eyes of twenty-three patients, the keratoconus staging was based on Amsler-Krumeich classification The ICRS surgery was performed with the patient under topical anesthesia. A tunnel channel was created by femtosecond laser using a 60-kHz infrared neodymium glass femtosecond laser at a wavelength of 1053 nm (Abbott Laboratories Inc., Abbott Park, Illinois, USA). Two symmetrical kerarings (Mediphacos Inc., Belo Horizonte, Brazil), were implanted in all cases with 160° arc and 0.25, 0.30 mm according to corneal thickness in implantation site. After surgery, the patients had a full ocular evaluation on days 1, 7, and 14, and again after a month. For a period of 1-year, corneal topography readings were taken quarterly.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • stable keratoconus.
  • corneal cross-linking performed at least 6 months.
  • contact lens intolerance
  • minimum corneal thickness of 350 μm at the thinnest point (TP)
  • mean keratometry (K mean) value less than 59 D

Exclusion criteria

  • any other associated ocular or systemic pathology could affect the vision.

Treatment and study plan

Intracorneal rings

Device

The (ICRS), intracorneal rings segments implantation surgery

Other names: INTACS

Primary outcomes

  1. K1 and K2 post-operative by Pentacam

    Time frame: one year

    Flat and Steep K in Diopter post ring implantation

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Clinical Outcomes of Two Symmetrical Kera-rings Implantation in Grade Three Keratoconus; A Retrospective Non-Randomized Study

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jul 12, 2024
Registry last updated
Jul 12, 2024

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.