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CompletedNCT01743443CSKUpdated Dec 6, 2012

Corneal Sensitivity Cross-linking Keratoconus

A Phase 2/3 interventional study of Cochet-Bonnet esthesiometer central corneal sensitivity in Keratoconus, sponsored by Instituto de Olhos de Goiania. Completed at 1 site in Brazil. Open to participants aged 18 Years to 26 Years. Per ClinicalTrials.gov, last updated 2012-12-06.

Sponsored by Instituto de Olhos de Goiania · Phase 2/3, Interventional, and Diagnostic

Phase
Phase 2/3
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years to 26 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Keratoconus

Keywords

  • Corneal sensitivity
  • Cross-linking
  • Keratoconus
03

In context

Keratoconus

307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.

This study's enrollment of 19 is below the median of 40 across 203 interventional studies indexed under Keratoconus.

Browse Keratoconus studies →

Lead sponsor

Instituto de Olhos de Goiania is the lead sponsor of 27 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 26 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • 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

Interventions

  • OtherCochet-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.

06

What researchers measure

Primary outcomes

  1. Corneal sensitivity

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

    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

07

Study locations

1 site
  • Instituto de Olhos de Goiania
    Goiania, GO 74120-050, Brazil
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 6, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01743443
Lead sponsor
Instituto de Olhos de Goiania
Responsible party
Joao Nassaralla (Chairman of IOG, Instituto de Olhos de Goiania) — Principal investigator
First posted
Dec 6, 2012
Start date
Mar 2009
Primary completion
Oct 2012
Completion
Oct 2012
Last update
Dec 6, 2012

Study contacts

Belquiz A Nassaralla, MD PhD
study chair · Instituto de Olhos de Goiania

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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