Pentacam Findings After Implantation of Intrastromal Corneal Rings in Keratoconus.

NCT ID: NCT04562064

Last Updated: 2022-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2022-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Keratoconus

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

corneal tomography scans

Intervention Type DEVICE

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

Interventions

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corneal tomography scans

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohamed Abbas

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut Faculty of Medicine

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Magdi M Mostafa, MD

Role: CONTACT

01093122344

Hani Elsodafy, MD

Role: CONTACT

01005263681

Facility Contacts

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Ahmed Abbas, MD

Role: primary

00201003385183

Other Identifiers

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PICR

Identifier Type: -

Identifier Source: org_study_id

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