NCT00384501

Brief Summary

Purpose To evaluate long-term follow up of Intacs microthin prescription inserts (Addition Technology Inc, Fremont, Calif) for the management of keratoconus. Design A long-term (five years) retrospective, follow-up study

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2000

Longer than P75 for not_applicable

Status
terminated

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
6.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 5, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
Last Updated

October 6, 2006

Status Verified

October 1, 2006

First QC Date

October 5, 2006

Last Update Submit

October 5, 2006

Conditions

Keratoconus

Keywords

keratoconusIntacs

Outcome Measures

Primary Outcomes (1)

  • refractive stability, UCVA, BSCVA, complications

Interventions

IntacsDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients had clear central corneas and contact lens intolerance (rigid gas permeable contact lenses intolerance, frequent contact lens displacement, unsatisfactory visual acuity),

You may not qualify if:

  • history of herpes keratitis; diagnosed autoimmune disease; and systemic connective tissue disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Alio JL, Shabayek MH, Artola A. Intracorneal ring segments for keratoconus correction: long-term follow-up. J Cataract Refract Surg. 2006 Jun;32(6):978-85. doi: 10.1016/j.jcrs.2006.02.044.

    PMID: 16814056RESULT

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • George D Kymionis, M.D., Ph.D

    University of Crete

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 5, 2006

First Posted

October 6, 2006

Study Start

January 1, 2000

Study Completion

July 1, 2006

Last Updated

October 6, 2006

Record last verified: 2006-10