NCT06498570

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2023

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 12, 2024

Completed
Last Updated

July 12, 2024

Status Verified

July 1, 2024

Enrollment Period

2 years

First QC Date

June 28, 2024

Last Update Submit

July 6, 2024

Conditions

Cornea Ectasia

Outcome Measures

Primary Outcomes (1)

  • K1 and K2 post-operative by Pentacam

    Flat and Steep K in Diopter post ring implantation

    one year

Study Arms (1)

grade 3 keratoconic eyes Grade 3 eyes with stable keratoconus

OTHER

grade 3 keratoconic eyes Grade 3 eyes with stable keratoconus

Device: Intracorneal rings

Interventions

Intracorneal ringsDEVICE

The (ICRS), intracorneal rings segments implantation surgery

Also known as: INTACS
grade 3 keratoconic eyes Grade 3 eyes with stable keratoconus

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elshimaa A.Mateen

Sohag, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 28, 2024

First Posted

July 12, 2024

Study Start

January 1, 2022

Primary Completion

December 20, 2023

Study Completion

January 10, 2024

Last Updated

July 12, 2024

Record last verified: 2024-07

Locations

EG(1)