NCT02008253

Brief Summary

To evaluate the clinical outcomes of intrastromal corneal ring segment (ICRS) implantation to correct keratoconus on eyes with prior refractive surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 1, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
Last Updated

December 11, 2013

Status Verified

December 1, 2013

Enrollment Period

3.5 years

First QC Date

December 1, 2013

Last Update Submit

December 6, 2013

Conditions

Ectasia

Keywords

INTRASTROMAL CORNEAL RINGASTIGMATISM

Outcome Measures

Primary Outcomes (1)

  • Intrastromal Corneal Ring Segment Implantation for Ectasia After Refractive Surgery

    To evaluate the clinical outcomes of intrastromal corneal ring segment (ICRS) implantation to correct keratoconus on eyes with prior refractive surgery. Corneal tunnels were created by means of mechanical dissection in all eyes. Main outcome measures included UCVA, BCVA, refraction, keratometry and computerized analysis of corneal topography.

    Mean follow-up after ICRS implantation was 12 months (range, 09 to 22 months).

Study Arms (1)

INTRASTROMAL CORNEAL RING SEGMENT

Forty-two eyes of 26 patients, 14 men and 12 women, with ectasia after refractive surgery were studied in a nonrandomized, retrospective, observational case series.

Procedure: INTRASTROMAL CORNEAL RING SEGMENT

Interventions

INTRASTROMAL CORNEAL RING SEGMENTPROCEDURE

Corneal tunnels were created by means of mechanical dissection in all eyes. Main outcome measures included UCVA, BCVA, refraction, keratometry and computerized analysis of corneal topography.

INTRASTROMAL CORNEAL RING SEGMENT

Eligibility Criteria

Age19 Years - 48 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients residents in Brazil with ectasia after refractive surgery

You may qualify if:

  • Patients 19 to 48 years old
  • Keratoconus (ectasia) on eyes with prior refractive surgery

You may not qualify if:

  • Diabetes
  • Autoimmune diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Olhos de Goiânia

Goiânia, Goiás, 74120-050, Brazil

Location

MeSH Terms

Conditions

Dilatation, PathologicAstigmatism

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsRefractive ErrorsEye Diseases

Study Officials

  • Larissa Rossana S Stival

    Instituto de Olhos de Goiânia

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2013

First Posted

December 11, 2013

Study Start

April 1, 2010

Primary Completion

October 1, 2013

Study Completion

November 1, 2013

Last Updated

December 11, 2013

Record last verified: 2013-12

Locations

BR(1)