Adapted Fluence Settings for Corneal Collagen Cross-linking in Mild to Moderate Progressive Keratoconus

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Brief Title

Adapted Fluence Settings for Corneal Collagen Cross-linking in Mild to Moderate Progressive Keratoconus

Official Title

Adapted Fluence Settings for Corneal Collagen Cross-linking in Progressive Mild to Moderate Keratoconus Aged 18 to 30

Brief Summary

      the purpose of this study is to compare the efficacy and safety of a new method of corneal
      cross-linking that uses UV-A irradiation intensity of 9mW/cm2 for 7 minutes to well-known
      Accelerated corneal cross-linking (9 mW/cm2 UV-A irradiation for 10 minutes)
    

Detailed Description

      This study is a Prospective interventional clinical trial comparing two groups of mild to
      moderate progressive keratoconic patients; Control group will be treated with routine
      accelerated protocol of corneal cross-linking, while exposure time will be decreased in the
      experimental group.

      we considered two groups of patients in our study:

        -  Group 1 (experimental): Exposure to 7 minutes at 9 mW/cm2 = 3.78 J/cm2

        -  Group 2 (controls): Exposure to 10 minutes at 9 mW/cm2 = 5.4 J/cm2

      All demographic data of patients, their uncorrected distance visual acuity (UCDVA), corrected
      distance visual acuity (BCDVA), sphere and cylinder refraction, keratometry readings (k1 and
      k2) and other topographic parameters of the patients before the procedure and at every follow
      up visit will be recorded.

      Corneal hysteresis and resistance factor will be checked by Ocular response analyzer before
      surgery and will be rechecked at 6 month follow up.

      Intraoperative pain will also be recorded based on the visual analog scale (VAS + FACES pain
      scale) immediately after the completion of surgery.

      Confocal microscopy will be used to evaluate changes in corneal stromal collagen fibers and
      keratocytes following cross-linking at 3 and 6 and 12 month post op period.

      All procedures will be done by a single surgeon. We will use topical anesthesia by tetracaine
      followed by mechanical epithelial debridement at a radius of 9 millimeters. Then riboflavin
      0.1% combined with dextran 20 % will be instilled every 3 minutes for 25 minutes. A short
      irrigation of the surface with BSS (to avoid a layer of riboflavin on the cornea during
      irradiation) will be performed. Corneal thickness will be determined by ultrasound
      pachymetry. If needed, hypoosmolar solution will be used to swell the cornea over 400 µm. If
      400 µm cannot be reached, then irradiation will not be performed. Then we will irradiate the
      eye by the UV A light source 5cm away from the eye with a light intensity of 9 mW/cm2 for 10
      minutes in control group and 7 minutes in experimental group and riboflavin will be instilled
      after 5 minutes for further in both groups, followed by a short irrigation of the surface
      with BSS (to avoid a layer of riboflavin on the cornea during irradiation).

      After the procedure we will apply a bandage contact lens for 5- 7 days and will prescribe
      topical betamethasone every 6 hours for 2 weeks, tapered to TDS, BID and HS weekly for a
      total duration 5 weeks. A topical antibiotic drop (Oftaquix every 6 hours) will be used for
      the first week.

      Patients will be followed up at day 1, day 6, 1 month, 3 months and 6 months and 12 months
      after surgery.
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

keratometric values on pentacam measured by Javal keratometer

Secondary Outcome

 clinical refraction

Condition

Keratoconus

Intervention

adjusted corneal collagen cross-linking

Study Arms / Comparison Groups

 experimental
Description:  Radiation: adjusted corneal collagen cross-linking (9mW/cm2 UV-A irradiation for 7 minutes after 30 mitunes of riboflavin instillation) riboflavin 0.1%: after mechanical epithelial removal riboflavin drop will be instilled every 5 minutes for 30 minutes and then instillation will be continued during irradiation epithelial debridement: corneal epithelium will be removed by a cottons swab

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Radiation

Estimated Enrollment

40

Start Date

August 2014

Completion Date

February 2016

Primary Completion Date

December 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Mild to moderate progressive KCN (Grade I and II) based on Amsler-krumeich
             classification; progression is defined as the old fashioned way in the lack of a
             consensus for more modern methods that is increase of > 1D of Kmax readings within 12
             months

          -  Age> 18 y, and <35 years

          -  Kmax lower than 58 D

          -  Signing informed consent form

        Exclusion Criteria:

          -  Any other ocular disease

          -  Corneal scar

          -  History of hydrops

          -  Any other ocular surgery including previous CCL, corneal inlay or keratorefractive
             surgery

          -  Inability to complete follow up schedule
      

Gender

All

Ages

18 Years - 30 Years

Accepts Healthy Volunteers

No

Contacts

Fateme Alipour, MD, , 

Location Countries

Iran, Islamic Republic of

Location Countries

Iran, Islamic Republic of

Administrative Informations


NCT ID

NCT02507362

Organization ID

ERC/S/9341


Responsible Party

Sponsor

Study Sponsor

Tehran University of Medical Sciences


Study Sponsor

Fateme Alipour, MD, Principal Investigator, Eye research center, Farabi eye hospital, Tehran university of medical science


Verification Date

July 2015