NCT06963099

Brief Summary

Intra-corneal rings implantation for correcting high cylinder errors in non ectatic corneas

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

1 active site

Status
recruiting

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

December 1, 2023

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 21, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 8, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

1.6 years

First QC Date

April 21, 2025

Last Update Submit

May 9, 2025

Conditions

Cornea

Outcome Measures

Primary Outcomes (2)

  • Change of (1)visual acuity in log mar (2) keratometry readings in diopter 1) refraction. 2)High order aberrations

    Using: (1) auto-refractometer (2) pentacam to assess keratometry changes.

    six months

  • changes of corneal parameters (K1.K2,K max) in diopter

    Comparing pentacam readings pre and post operative.

    six months

Study Arms (1)

High cylinder group

OTHER
Other: INTACS implantation

Interventions

INTACS implantationOTHER

intra corneal segments implantation

High cylinder group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Non ectatic corneas with high cylinder error

You may not qualify if:

  • Corneal ectasia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elshimaa A.Mateen

Sohag, Egypt

RECRUITING

MeSH Terms

Conditions

Corneal Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Elshimaa A.Mateen, Doctor

CONTACT

0021282223427elshimaa.moussa@yahoo.com

Study Design

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

Study Record Dates

First Submitted

April 21, 2025

First Posted

May 8, 2025

Study Start

December 1, 2023

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

May 14, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)