Intraestromal Corneal Ring in Mild Keratoconus

Keratoconus Clinical Trial

Official title:

Intrastromal Corneal Ring Was Effective for the Treatment of Mild Keratoconus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03127163
• Other study ID #: 0591/11
• Status: Completed
• Phase: N/A
• First received: April 12, 2017
• Last updated: April 23, 2017
• Start date: January 10, 2015
• Est. completion date: January 10, 2017

Study information

• Verified date: April 2017
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To determine whether the implantation of an intrastromal corneal ring is an effective treatment for a homogeneous group of mild keratoconus patients.

Description:

A group of 65 patients with mild keratoconus were implanted with a Ferrara ring in a single eye. Six months after surgery, the aberrations were measured and the visual function was determined using clinical indices. The aberrations, especially comatic aberration (coma), were measured independently.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: January 10, 2017
• Est. primary completion date: January 10, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years to 47 Years

Eligibility

Inclusion Criteria:

• Investigators used the Amsler-Krumeich classification and included only patients classified as grade I or II.

Exclusion Criteria:

• Investigators excluded patients with central corneal scarring, with other eye disorders, or with previous ocular surgery. We also excluded patients with a history of herpes infection, keratitis, corneal dystrophies, diagnoses of autoimmune diseases, systemic connective tissue disorders, or acute keratoconus.

Related Conditions & MeSH terms

• Cornea
• Eye Diseases
• Keratoconus
• Ophthalmological Disorder

Intervention

Device:
• Intraestromal corneal ring
The patients underwent surgery to implant the intrastromal corneal ring (Ferrara Ophthalmics, Belo Horizonte, Brazil) using a manual technique. The procedures were performed by a single surgeon with extensive training in corneal surgery. All patients received the same ring, and the number (1 or 2 segments), thickness, and arc size were calculated using the nomogram provided by the manufacturer.

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aberrations were measured and the visual function was determined using clinical indices.	Wave front data	3 months after surgery
Secondary	UCVA	Uncorrected visual acuity	3 months after surgery
Secondary	BCVA	Best corrected visual acuity	3 months after surgery