NCT00347230

Brief Summary

To study the effects Intacs intracorneal ring segments(Addition Technology, Inc) insertion in the treatment of keratoconus

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 30, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 4, 2006

Completed
Last Updated

July 7, 2006

Status Verified

September 1, 2005

First QC Date

June 30, 2006

Last Update Submit

July 3, 2006

Conditions

Keratoconus

Keywords

Intacs ring segmentsKeratoconus

Outcome Measures

Primary Outcomes (3)

  • Visual acuity

  • Refraction

  • Corneal topography

Secondary Outcomes (1)

  • Patient satisfaction following procedure

Interventions

Intacs intracorneal ring insertion for the treatment of keratoconusDEVICE

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must have keratoconus (mild to moderate).
  • Visual acuity with contact lenses must be better than or equal to (20/40).
  • Patients must be intolerant of contact lenses, i.e., they must be unable to wear contact lenses for a whole day.
  • Patients will have a corneal thickness of 425 microns at the site of ICRS (INTACS inserts) placement (the thinnest region of the cornea).
  • In terms of general health, patients must not have any illnesses posing an immediate threat to life.
  • Patients must have provided written informed consent at least one week prior to surgery.
  • Patients must over 21 years of age.
  • Patients' contact lenses must have been removed at least one week prior to surgery for soft lenses and two weeks prior to surgery for hard lenses.

You may not qualify if:

  • Positive pregnancy test.
  • Breast-feeding.
  • History of previous ophthalmologic surgery on the operative eye.
  • Patients with corneal stromal disorders.
  • Patients with history of herpetic keratitis.
  • Patients with retinal disorders.
  • Corneal grafts.
  • Patients refusing to remove contact lenses one week before surgery for soft lenses and two weeks before surgery for hard lenses.
  • Patients with amblyopia (VA \<1110 for the contralateral eye).
  • Patients with corneal thickness \<425 microns.
  • Patients with TOP \<10 mmHg or \>21 mmHg.
  • Patients taking part in other biomedical research in the 30 days prior to the start of this study.
  • Patients with an uncooperative disposition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Singapore National Eye Centre

Singapore, 168751, Singapore

RECRUITING

Related Publications (5)

  • Colin J, Cochener B, Savary G, Malet F, Holmes-Higgin D. INTACS inserts for treating keratoconus: one-year results. Ophthalmology. 2001 Aug;108(8):1409-14. doi: 10.1016/s0161-6420(01)00646-7.

    PMID: 11470691BACKGROUND

  • Colin J, Cochener B, Savary G, Malet F. Correcting keratoconus with intracorneal rings. J Cataract Refract Surg. 2000 Aug;26(8):1117-22. doi: 10.1016/s0886-3350(00)00451-x.

    PMID: 11008037BACKGROUND

  • Siganos D, Ferrara P, Chatzinikolas K, Bessis N, Papastergiou G. Ferrara intrastromal corneal rings for the correction of keratoconus. J Cataract Refract Surg. 2002 Nov;28(11):1947-51. doi: 10.1016/s0886-3350(02)01495-5.

    PMID: 12457667BACKGROUND

  • Schanzlin DJ, Asbell PA, Burris TE, Durrie DS. The intrastromal corneal ring segments. Phase II results for the correction of myopia. Ophthalmology. 1997 Jul;104(7):1067-78. doi: 10.1016/s0161-6420(97)30183-3.

    PMID: 9224455BACKGROUND

  • Siganos CS, Kymionis GD, Kartakis N, Theodorakis MA, Astyrakakis N, Pallikaris IG. Management of keratoconus with Intacs. Am J Ophthalmol. 2003 Jan;135(1):64-70. doi: 10.1016/s0002-9394(02)01824-x.

    PMID: 12504699BACKGROUND

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Donald TH Tan, FRCS

    Singapore National Eye Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Li - Lim, FRCS(Ed)

CONTACT

65-63228896Lim.Li@snec.com.sg

Donald TH Tan, FRCS

CONTACT

65-63224500snecdt@pacific.net.sg

Study Design

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

Study Record Dates

First Submitted

June 30, 2006

First Posted

July 4, 2006

Study Start

October 1, 2005

Last Updated

July 7, 2006

Record last verified: 2005-09

Locations

SG(1)