NCT01018797

Brief Summary

To evaluate the clinical outcomes of Intrastromal Corneal Ring Segment (ICRS) implantation to correct high-degree astigmatism on eyes with prior penetrating keratoplasty (PK).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2007

Typical duration for phase_4

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

January 1, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 25, 2009

Completed
Last Updated

November 25, 2009

Status Verified

November 1, 2009

Enrollment Period

2.5 years

First QC Date

November 21, 2009

Last Update Submit

November 23, 2009

Conditions

Astigmatism

Keywords

INTRASTROMAL CORNEAL RINGASTIGMATISMPOSTKERATOPLASTYEYESTo evaluate the clinical outcomes of ICRS implantation to correct high-degree astigmatism on eyes with prior penetrating keratoplasty (PK)

Study Arms (1)

INTRASTROMAL CORNEAL RING SEGMENT

EXPERIMENTAL

Eighteen eyes of 18 patients, 8 men and 10 women, with high levels (\> 5 diopters \[D\]) of postkeratoplasty astigmatism were studied in a nonrandomized, retrospective, observational case series. PK was performed to treat keratoconus in 15 patients, corneal scar after trauma in 2 patients, and Fuchs endothelial dystrophy in 1 patient.

Procedure: INTRASTROMAL CORNEAL RING SEGMENT

Interventions

INTRASTROMAL CORNEAL RING SEGMENTPROCEDURE

Corneal tunnels were created by means of mechanical dissection in all eyes. Intrastromal corneal ring segments implantation was indicated because of the existence of reduced best spectacle-corrected visual acuity (BSCVA) or contact lens intolerance.

INTRASTROMAL CORNEAL RING SEGMENT

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • \> 5 diopters of postkeratoplasty astigmatism
  • Patients 21 to 50 years old
  • Conventional treatments have failed

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

Astigmatism

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Belquiz A Nassaralla

    Instituto de Olhos de Goiânia

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 21, 2009

First Posted

November 25, 2009

Study Start

January 1, 2007

Primary Completion

July 1, 2009

Study Completion

November 1, 2009

Last Updated

November 25, 2009

Record last verified: 2009-11

Locations

BR(1)