NCT02189447

Brief Summary

Evaluation of the safety and efficacy of surface ablation followed by Collagen Cross-linking in patients with keratoconus

Trial Health

100
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2011

Typical duration for not_applicable

Status
completed

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

January 1, 2011

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 14, 2014

Completed
Last Updated

July 14, 2014

Status Verified

July 1, 2014

Enrollment Period

2.7 years

First QC Date

July 5, 2014

Last Update Submit

July 10, 2014

Conditions

Keratoconus

Keywords

KeratoconusEctasiaCorneal Cross-linking

Outcome Measures

Primary Outcomes (1)

  • The change of visual acuity following Photorefractive Keratectomy and Corneal Collagen Cross-linking in patients with Keratoconus

    The change of visual acuity from baseline in patients suffering from keratoconus following treatment with Photorefractive Keratectomy and Corneal Collagen Cross-linking.

    6 months

Study Arms (1)

Refractive surgery

EXPERIMENTAL

Patients with keratoconus treated with simultaneous photorefractive keratectomy and Corneal collagen cross-linking.

Procedure: Simultaneous Photorefractive Keratectomy and Collagen Cross-linking in patients with keratoconus

Interventions

Simultaneous Photorefractive Keratectomy and Collagen Cross-linking in patients with keratoconusPROCEDURE

Photorefractive Keratectomy followed by Collagen Cross-linking in patients with keratoconus in the same surgical setting

Refractive surgery

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • contact lens intolerance
  • corneal thickness \> 450 micrometers
  • Keratometry \< 56 diopters
  • Astigmatism \< 6 diopters

You may not qualify if:

  • corneal thickness \< 450 micrometers
  • Keratometry \> 56 diopters
  • Astigmatism \> 6 diopters

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

KeratoconusDilatation, Pathologic

Condition Hierarchy (Ancestors)

Corneal DiseasesEye DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2014

First Posted

July 14, 2014

Study Start

January 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

July 14, 2014

Record last verified: 2014-07