- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07540208
Keraring Implantation Based on Alfonso Nomogram
April 17, 2026 updated by: Mahmoud Abdel-Radi, Assiut University
Outcomes of Keraring Implantation in Patients With Keratoconus Guided by the Alfonso Morphological Surgical Nomogram
Keratoconus (KC) is a bilateral asymmetric progressive corneal degenerative disease associated with corneal thinning and protrusion.
The management of moderate progressive keratoconus involves halting its progression through corneal cross-linking as well as flattening of the ectatic steep cornea through the implantation of intrastromal corneal rings (ICR).
Different nomograms were used to guide ophthalmic surgeons for the proper choice of ICR implantation to achieve the best results.
The aim of the current study is to assess the visual, refractive and tomographic outcomes of Keraring implantation based on the Alfonso nomogram, in patients with keratoconus.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Asyut Governorate
-
Asyut, Asyut Governorate, Egypt, 71515
- TIBA Eye Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients aged between 18-35 years.
- Patients diagnosed with progressive keratoconus.
- Mean keratometry (Km) between 48-60 D.
- Clear cornea
Exclusion Criteria:
- Mild or advanced keratoconus
- Corneal scarring.
- Other corneal or ocular diseases.
- Systemic diseases such as diabetes mellitus and autoimmune diseases.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Keraring implantation based on Alfonso nomogram
Patients with moderate progressive keratoconus, underwent Keraring implantation based on Alfonso morphological surgical nomogram.
|
Patients with moderate progressive keratoconus underwent femtosecond laser-assisted intrastromal corneal ring (Keraring) implantation based on the Alfonso morphological surgical nomogram.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Corrected distance visual acuity
Time Frame: 6 months
|
Corrected distance visual acuity is measured with Snellen's acuity chart and converted to logarithm of the minimum angle of resolution (logMAR) notation.
|
6 months
|
|
Spherical equivalent refraction
Time Frame: 6 months
|
Spherical equivalent in diopters is measured with Topcon autorefractometer.
|
6 months
|
|
Maximum keratometry
Time Frame: 6 months
|
The maximum keratometry in diopters is measured using pentacam.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 1, 2025
Primary Completion (Actual)
March 1, 2026
Study Completion (Estimated)
September 1, 2026
Study Registration Dates
First Submitted
April 13, 2026
First Submitted That Met QC Criteria
April 17, 2026
First Posted (Actual)
April 20, 2026
Study Record Updates
Last Update Posted (Actual)
April 20, 2026
Last Update Submitted That Met QC Criteria
April 17, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OKIPKGASN
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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