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

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

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

Study Overview

• Status: Completed
• Conditions: Cornea Ectasia
• Intervention / Treatment: Device: Intracorneal rings

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt
    • Elshimaa A.Mateen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: grade 3 keratoconic eyes Grade 3 eyes with stable keratoconus	Device: Intracorneal rings; The (ICRS), intracorneal rings segments implantation surgery; Other Names: INTACS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
K1 and K2 post-operative by Pentacam	Flat and Steep K in Diopter post ring implantation	one year

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): December 20, 2023
• Study Completion (Actual): January 10, 2024

Study Registration Dates

• First Submitted: June 28, 2024
• First Submitted That Met QC Criteria: July 6, 2024
• First Posted (Actual): July 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 12, 2024
• Last Update Submitted That Met QC Criteria: July 6, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: Soh-MED-24-05--03PD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No