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Corneal Sensitivity Cross-linking Keratoconus (CSK)

Primary Purpose

Keratoconus

Status

Completed

Phase

Phase 2

Locations

Brazil

Study Type

Interventional

Intervention

Cochet-Bonnet esthesiometer central corneal sensitivity

About this trial

This is an interventional diagnostic trial for Keratoconus focused on measuring Corneal sensitivity, Cross-linking, Keratoconus

Eligibility Criteria

18 Years - 26 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Instituto de Olhos de Goiania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sensitiviy

Arm Description

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.

Outcomes

Primary Outcome Measures

Corneal sensitivity

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01743443

First Posted

December 1, 2012

Last Updated

December 4, 2012

Sponsor

Instituto de Olhos de Goiania

1. Study Identification

Unique Protocol Identification Number

NCT01743443

Brief Title

Corneal Sensitivity Cross-linking Keratoconus

Acronym

CSK

Official Title

Corneal Sensitivity Changes Following Cross-linking for Progressive Lower Stage Keratoconus

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

March 2009 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Instituto de Olhos de Goiania

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Keratoconus

Keywords

Corneal sensitivity, Cross-linking, Keratoconus

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2, Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sensitiviy

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Cochet-Bonnet esthesiometer central corneal sensitivity

Intervention Description

Primary Outcome Measure Information:

Title

Corneal sensitivity

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

26 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Belquiz A Nassaralla, MD PhD

Organizational Affiliation

Instituto de Olhos de Goiania

Official's Role

Study Chair

Facility Information:

Facility Name

Instituto de Olhos de Goiania

City

Goiania

State/Province

ZIP/Postal Code

74120-050

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

Corneal Sensitivity Cross-linking Keratoconus

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