Corneal Sensitivity Cross-linking Keratoconus (CSK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Joao Nassaralla, Instituto de Olhos de Goiania
ClinicalTrials.gov Identifier:
NCT01743443
First received: December 1, 2012
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

To evaluate corneal sensitivity changes following corneal cross-linking (CXL) in patients with progressive lower stage keratoconus.


Condition Intervention Phase
Keratoconus
Other: Cochet-Bonnet esthesiometer central corneal sensitivity
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Corneal Sensitivity Changes Following Cross-linking for Progressive Lower Stage Keratoconus

Resource links provided by NLM:


Further study details as provided by Instituto de Olhos de Goiania:

Primary Outcome Measures:
  • Corneal sensitivity [ Time Frame: Central corneal sensitivity was measured preoperatively, after 7 days, and once a month after surgery until recovery of the baseline preoperative level. The avarage was 12 weeks ] [ Designated as safety issue: Yes ]
    To evaluate corneal sensitivity changes following corneal cross-linking (CXL) in patients with progressive lower stage keratoconus.


Enrollment: 19
Study Start Date: March 2009
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sensitiviy
Using the Cochet-Bonnet esthesiometer central corneal sensitivity was measured preoperatively, after 7 days, and once a month after surgery until recovery of the baseline preoperative level. Normal levels of central corneal sensitivity were considered above 40mm.
Other: Cochet-Bonnet esthesiometer central corneal sensitivity
Using the Cochet-Bonnet esthesiometer central corneal sensitivity was measured preoperatively, after 7 days, and once a month after surgery until recovery of the baseline preoperative level. Normal levels of central corneal sensitivity were considered above 40mm.

Detailed Description:

Thirty eight eyes of 19 patients (11 women, 8 men) were included in a prospective, nonrandomized clinical study. Mean patient age was 22 years (range, 18-26 years). Inclusion criteria were low stage bilateral progressive keratoconus, transparent cornea and thinnest corneal thickness ≥ 440 µm. Using the Cochet-Bonnet esthesiometer central corneal sensitivity was measured preoperatively, after 7 days, and once a month after surgery until recovery of the baseline preoperative level. Normal levels of central corneal sensitivity were considered above 40mm.

  Eligibility

Ages Eligible for Study:   18 Years to 26 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be at least 18 years of age
  • Provide written consent and sign a HIPAA form
  • Willingness and ability to follow all instructions and comply with schedule for follow-up visits
  • For females capable of becoming pregnant,agreet o have uurine pregnancy testing performed prior to treatment; must not be lactating, and must agree to use a medically acceptable form of birth control for at least one week prior to the treatment and continue to use the method until 1 month after the last dose of investigational product.
  • Having topographic evidence of keratoconus which is graded as lower stage progressive keratoconus
  • Presence of central or inferior steepening on the Pentacam map
  • Steepest keratometry (Kmax) value greater than or equal to 51.00D
  • BSCVA of 80 letters or fewer for keratoconus on ETDRS chart
  • Contact lens wearers only: remove contact lenses one week prior to the screening refraction
  • Contact lens wearers only: manifest refraction must be stable between two visits that occur at least 7 days apart

Exclusion Criteria:

  • Contraindications, sensitivity or known allergy to the use of the test articles(S) or their components
  • If female, be pregnant, nursing, or planning a pregnancy or have a positive urine pregnancy test at Visit 2 prior to treatment or during the course of the study
  • Eyes classified as either normal,atypical normal,keratoconus suspect or mild keratoconus on the severity grading scheme
  • A history of the insertion of INTACS in the eye to be treated
  • A history of previous limbal relaxing incision procedure in the eye to be treated
  • Corneal pachymetry that is <350 microns at the thinnest point measured by Pentacam in the eye to be treated
  • Eyes which are aphakic
  • Eyes which are pseudophakic and do not have a UV blocking lens implanted
  • Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications.
  • A history of delayed epithelial healing in the eye to be treated
  • Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests
  • Patients with a currnet condition that, in the investigator's opinion,would interfere with or prolong epithelial healing
  • Taking Vitamin C (ascorbic acid) supplements within 1 week of the crosslinking treatment
  • A history of previous corneal crosslinking treatment in the eye to be treated
  • Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01743443

Locations
Brazil
Instituto de Olhos de Goiania
Goiania, GO, Brazil, 74120-050
Sponsors and Collaborators
Instituto de Olhos de Goiania
Investigators
Study Chair: Belquiz A Nassaralla, MD PhD Instituto de Olhos de Goiania
  More Information

No publications provided

Responsible Party: Joao Nassaralla, Chairman of IOG, Instituto de Olhos de Goiania
ClinicalTrials.gov Identifier: NCT01743443     History of Changes
Other Study ID Numbers: ARVO - BN - 2013
Study First Received: December 1, 2012
Last Updated: December 4, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Instituto de Olhos de Goiania:
Corneal sensitivity
Cross-linking
Keratoconus

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 22, 2014