Pentacam Findings After Implantation of Intrastromal Corneal Rings in Keratoconus.

NCT04562064 | Unknown

• 1 other identifier: PICR
• Study Type: observational
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

keratoconus is a progressive corneal ectatic disease characterized by paraxial stromal thinning and weakening, resulting in irregular astigmatism, corneal protrusion, and distortion of the anterior corneal surface. It is usually bilateral, although asymmetrical in most cases. Intrastromal corneal rings are polymethylmethacrylate devices successfully used for the management of keratoconus, pellucid marginal degeneration, post-LASIK ectasia and myopia. Intrastromal corneal rings implantation is safe and reversible procedure that does not affect the central corneal area, and hence, avoids interference with visual axis. The goal of intrastromal corneal rings implantation is to improve visual acuity by regulariztion of the anterior corneal surface.

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

• The percentage of changes of anterior corneal surface preoperatively compared to those values postoperativaly

  The changes of anterior corneal surface including flat (K1) and steep (K2) keratometry values, corneal astigmatism (Astig) preoperatively compared to those values postoperativaly

  1 month

Study Arms (1)

keratoconus group

patients with keratoconus implanted with the Myoring 360 degree, KeraRing 355 degree, KeraRing one segment, KeraRing two segments ICRS .corneal tomography scans of the two corneal surfaces were obtained preoperatively and postoperatively with a rotating Scheimpflug imaging system .pentacam data that will be included

Device: corneal tomography scans

Interventions

corneal tomography scans DEVICE

corneal tomography scans of the two corneal surfaces were obtained preoperatively and postoperatively with a rotating Scheimpflug imaging system

keratoconus group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients with keratoconus implanted with the Myoring 360 degree, KeraRing 355 degree, KeraRing one segment, KeraRing two segments ICRS .corneal tomography scans of the two corneal surfaces were obtained preoperatively and postoperatively with a rotating Scheimpflug imaging system .pentacam data that will be included

You may qualify if:

• Keratoconus grade I, II and III according to the mean K Amsler-Krumeich classification.
• Contact lens intolerance.
• Thinnest location is more than 400 um.
• Maximum keratometry (Kmax) between 48 and 64 D.
• Clear cornea with no Vogt's striae.

You may not qualify if:

• Previous corneal surgery.
• Grade IV with corneal scarring.
• Concurrent corneal disease in addition to KC.
• Autoimmune or systemic connective tissue diseases.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut Faculty of Medicine

Asyut, Egypt

RECRUITING

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Central Study Contacts

Magdi M Mostafa, MD

CONTACT

01093122344; magdimohammad2013@gmail.com

Hani Elsodafy, MD

CONTACT

01005263681; hanyelsedfy@yahoo.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 18, 2020
• First Posted: September 24, 2020
• Study Start: December 1, 2020
• Primary Completion: September 1, 2022
• Study Completion: November 1, 2022
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)