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

Not Applicable

Completed

• Conditions: Cornea Ectasia
• Interventions: Device: Intracorneal rings

• Registration Number: NCT06498570
• Lead Sponsor: Sohag University

Brief Summary

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

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 Timeline

• Study Start: 2022-01-01
• Primary Completion: 2023-12-20
• Study Completion: 2024-01-10
• Study First Submitted: 2024-06-28
• Status Verified: 2024-07
• Study First Submitted QC: 2024-07-06
• Last Update Submitted: 2024-07-06
• Study First Posted: 2024-07-12
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
grade 3 keratoconic eyes Grade 3 eyes with stable keratoconus	Intracorneal rings	grade 3 keratoconic eyes Grade 3 eyes with stable keratoconus

Primary Outcome Measures

Name	Time	Method
K1 and K2 post-operative by Pentacam	one year	Flat and Steep K in Diopter post ring implantation

Trial Locations

Locations (1)

Elshimaa A.Mateen; 🇪🇬 Sohag, Egypt