NCT02507362

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

August 6, 2014

Completed
12 months until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

1.3 years

First QC Date

August 6, 2014

Last Update Submit

July 22, 2015

Conditions

Keratoconus

Keywords

keratoconus , corneal collagen cross-linking

Outcome Measures

Primary Outcomes (3)

  • keratometric values on pentacam measured by Javal keratometer

    one year

  • best corrected visual acuity

    one year

  • uncorrected distant visual acuity

    one year

Secondary Outcomes (2)

  • clinical refraction

    one year

  • endothelial cell count

    one year

Other Outcomes (4)

  • corneal thickness

    one year

  • corneal hysteresis

    one year

  • corneal resistance factor

    one year

  • +1 more other outcomes

Study Arms (2)

experimental

EXPERIMENTAL

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

Radiation: adjusted corneal collagen cross-linkingDrug: riboflavin 0.1% combined with dextran 20 %Procedure: epithelial debridement

control

ACTIVE COMPARATOR

radiation: accelerated corneal collagen cross-linking (9mW/cm2 UV-A irradiation for 10 minutes after 30 minutes 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

Radiation: accelerated corneal collagen cross-linkingDrug: riboflavin 0.1% combined with dextran 20 %Procedure: epithelial debridement

Interventions

adjusted corneal collagen cross-linkingRADIATION

UV-A irradiation for 7 minutes

experimental
accelerated corneal collagen cross-linkingRADIATION

UV-A irradiation for 10 minutes

control
riboflavin 0.1% combined with dextran 20 %DRUG

after mechanical epithelial removal riboflavin drop will be instilled every 5 minutes for 30 minutes and then instillation will be continued during irradiation

controlexperimental
epithelial debridementPROCEDURE

corneal epithelium will be removed by a cottons swab

Also known as: epithelium removal
controlexperimental

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Farabi eye hospital

Tehran, Tehran Province, 1336616351, Iran

Location

MeSH Terms

Conditions

Keratoconus

Interventions

RiboflavinSubgingival Curettage

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

FlavinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsHeterocyclic Compounds, 3-RingCoenzymesEnzymes and CoenzymesPigments, BiologicalBiological FactorsPeriodonticsDentistry

Study Officials

  • Fateme Alipour, MD

    Eye research center, Farabi eye hospital, Tehran university of medical science

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2014

First Posted

July 23, 2015

Study Start

August 1, 2014

Primary Completion

December 1, 2015

Study Completion

February 1, 2016

Last Updated

July 23, 2015

Record last verified: 2015-07

Locations

IR(1)