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Intacs for Keratoconus
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2005 by Singapore National Eye Centre.   Recruitment status was  Recruiting

First Received on June 30, 2006.   Last Updated on July 3, 2006   History of Changes
Sponsor: Singapore National Eye Centre
Information provided by: Singapore National Eye Centre
ClinicalTrials.gov Identifier: NCT00347230
  Purpose

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


Condition Intervention
Keratoconus
 Device: Intacs intracorneal ring insertion for the treatment of keratoconus

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intacs for Keratoconus

Further study details as provided by Singapore National Eye Centre:

Primary Outcome Measures:
  • Visual acuity
  • Refraction
  • Corneal topography

Secondary Outcome Measures:
  • Patient satisfaction following procedure

Estimated Enrollment: 20
Study Start Date: October 2005
Detailed Description:

The purpose of this evaluation is to study the effects of implanting INTACS inserts, identical to those commercially available to correct myopia, into the corneal stroma of patients with keratoconus (mild to moderate) and having a clear cornea. The principle of the procedure is to flatten the cornea deformed by keratoconus. One or two segments of the same or a different thickness will be selected to reduce the asymmetric astigmatism responsible for the patient impaired visual acuity.

The surgical technique is based on locating the INTACS inserts on the flattest axis of the refractive error, making the incision on the steepest axis, using 150 degree arc length inserts with different sizes (0.250, 0.300, 0.350, 0.400 & 0.450 mm) according to a nomogram designed for this technique using the INTACS Instrumentation (10-Step Prolate System instruments).

The corneal lamellar channel creation may be performed using the INTACS instrumentation or using the Femtosecond laser (Femtec 20/10 laser[Femtec,Heidelberg Germany])

Primary Assessment Criteria

  • Evaluation of the safety of the device for the treatment of patients with keratoconus (mild to moderate)
  • Maintenance of best corrected visual acuity (BCVA)
  • Improvement in uncorrected visual acuity (UCVA)
  • Reduction in manifest refraction spherical equivalent
  • Reduction in asymmetric astigmatism

Secondary Assessment Criteria

  • Evaluation of the effect of INTACS inserts placement for treatment of corneal ectasia
  • Determination of patient satisfaction following the INTACS inserts procedure Patients meeting the eligibility criteria are required to sign a Patient Informed Consent Form prior to study participation.

A thorough examination is perform to evaluate the following:

  • Manifest refraction results - Uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA)
  • Cycloplegic refraction results - Uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA)
  • Corneal topography
  • Pachymetry
  • Step axis location
  • Location of incision placement
  • Subjective feedback about quality of vision (Excellent, Good, Fair and Poor)

Post-operative Assessment(at 1 day, 1 week, 1 month and 3 months postop)

  • Uncorrected visual acuity (UCVA) and best corrected visual acuity with manifest refraction(BCVA) at designated time interval
  • Cycloplegic refraction results - Uncorrected visual acuity (UCVA) and best corrected visual acuity (BCVA) at designated time interval
  • Corneal topography at designated time interval
  • Pachymetry at designated time interval
  • Subjective visual outcome ratings over time (Excellent, Good, Fair and Poor)
  • Report adverse events
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00347230

Contacts
Contact: Li - Lim, FRCS(Ed) 65-63228896 ext - Lim.Li@snec.com.sg
Contact: Donald TH Tan, FRCS 65-63224500 ext - snecdt@pacific.net.sg

Locations
Singapore
Singapore National Eye Centre Recruiting
Singapore, Singapore, 168751
Sub-Investigator: Li - Lim, FRCS(Ed)            
Sponsors and Collaborators
Singapore National Eye Centre
Investigators
Principal Investigator: Donald TH Tan, FRCS Singapore National Eye Centre
  More Information

Publications:
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.
Colin J, Cochener B, Savary G, Malet F. Correcting keratoconus with intracorneal rings. J Cataract Refract Surg. 2000 Aug;26(8):1117-22.
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.
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.
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.

ClinicalTrials.gov Identifier: NCT00347230     History of Changes
Other Study ID Numbers: R419/14/2005
Study First Received: June 30, 2006
Last Updated: July 3, 2006
Health Authority: Singapore: Health Sciences Authority

Keywords provided by Singapore National Eye Centre:
Intacs ring segments
Keratoconus

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on February 12, 2012



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