NCT02721628

Brief Summary

Epi-keratoplasty Versus Collagen Cross-Linking in Progressive Keratoconus

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
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

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

September 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 6, 2016

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 29, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 29, 2016

Status Verified

March 1, 2016

Enrollment Period

2.3 years

First QC Date

March 6, 2016

Last Update Submit

March 22, 2016

Conditions

Progressive Keratoconus

Keywords

Keratoconus

Outcome Measures

Primary Outcomes (1)

  • Changes of Spherical equivalent

    01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years

Secondary Outcomes (3)

  • maximum keratometry (K-max) derived from computerized video keratography

    01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years

  • minimum keratometry

    01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years

  • Visual acuity

    01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years

Other Outcomes (1)

  • Spherical equivalent

    01012016~01012018: preoperatively, postoperatively 2 weeks, 1,2,3,6,12 months, 2 years

Study Arms (2)

Epi-keratoplasty Group

EXPERIMENTAL

Epi-keratoplasty Group: Reversible keratoplasty performed with only the removal of corneal epithelium of the host cornea. A donor graft is transplanted on the recipients' eye locating on the Bowman's layer.

Procedure: Epi-keratoplastyDevice: Femtosecond laser

Collagen Cross-Linking Group

ACTIVE COMPARATOR

Collagen Cross-Linking: Corneal epithelium is mechanically removed. Then, a solution of riboflavin is instilled each minute for 30 minutes. Corneas are irradiated by a UVA light for 3mW/cm2 during 30 minutes

Procedure: Collagen Cross-Linking

Interventions

Epi-keratoplastyPROCEDURE

Femtosecond laser assisted Epi-keratoplasty

Epi-keratoplasty Group
Collagen Cross-LinkingPROCEDURE

Collagen Cross-Linking: Standard procedure, which is descriptor bellows: Corneal epithelium is mechanically removed. Then, a solution of riboflavin is instilled each minute for 30 minutes. Corneas are irradiated by a UVA light for 3mW/cm2 during 30 minutes

Also known as: CCL
Collagen Cross-Linking Group
Femtosecond laserDEVICE

Use in the epic-keratoplasty surgery

Epi-keratoplasty Group

Eligibility Criteria

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

You may qualify if:

  • diagnosis of Keratoconus
  • Age ≥ 18 years old
  • Corneal thickness ≥ 400 µm
  • Progressive stage 1 to 3 keratoconus (Krumeich classification)

You may not qualify if:

  • Corneal thickness \< 400µm
  • Concomitant corneal disease
  • History of corneal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ZhongShan Ophthalmic Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Central Study Contacts

Xinbo Gao, MD, PHD

CONTACT

+8613570942794ice.freeport@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attendant Doctor

Study Record Dates

First Submitted

March 6, 2016

First Posted

March 29, 2016

Study Start

September 1, 2015

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

March 29, 2016

Record last verified: 2016-03

Locations

CN(1)