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Intrastromal Corneal Ring Segment Implantation in 219 Keratoconic Eyes at Different Stages

NCT ID: NCT01261013

Last Updated: 2010-12-27

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

COMPLETED

Total Enrollment

219 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-01-31

Study Completion Date

2010-03-31

Brief Summary

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The purpose of this study is to properly analyse the visual and refractive outcomes of implantation of KeraRing intrastromal corneal ring segment (ICRS) at the different stages of keratoconus.

Detailed Description

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Conditions

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Keratoconus

Keywords

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Keratoconus intrastromal corneal ring segment To evaluate the visual and refractive outcomes of intrastromal corneal ring segment in keratoconic eyes at different stages

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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keratoconus stage I in whom KeraRing ICRS were implanted

No interventions assigned to this group

keratoconus stage II in whom KeraRing ICRS were implanted

No interventions assigned to this group

keratoconus stage III in whom KeraRing ICRS were implanted

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients who had keratoconus
* Contact lens intolerance and clear cornea.
* The maximum keratometric reading was less than 60.00 diopters (D)
* The minimum corneal thickness more than 300 μm.

Exclusion Criteria

* Acute or grade IV keratoconus.
* Previous corneal or intraocular surgery.
* Cataract, history of glaucoma or retinal detachment, macular degeneration or retinopathy, neuro-ophthalmic diseases, and history of ocular inflammation
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fernandez-Vega Ophthalmological Institute

OTHER

Sponsor Role lead

Other Identifiers

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IOFV-1

Identifier Type: -

Identifier Source: org_study_id