NCT03450213

Brief Summary

Keratoconus is a bilateral (but usually asymmetrical) non-inflammatory progressive thinning process of the cornea. It manifests as characteristic cone-like ectasia of the cornea associated with irregular stromal thinning, resulting in a cone-like bulge , which causing irregular astigmatism and vision impairment.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

February 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
1.6 years until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

1 year

First QC Date

February 23, 2018

Last Update Submit

October 15, 2018

Conditions

Keratoconus

Outcome Measures

Primary Outcomes (1)

  • Comparison between astigmatism in patients with keratoconus and normal people.

    Pentacam will be used for comparison between astigmatism in patients with keratoconus and normal people at the same age and sex

    Two years

Study Arms (2)

Patients with keratoconus

ACTIVE COMPARATOR

Pentacam will be used for comparison between astigmatism in patients with keratoconus and normal people at the same age and sex.

Device: Pentacam

Normal people at the same age and sex

PLACEBO COMPARATOR

Pentacam will be used for comparison between astigmatism in patients with keratoconus and normal people at the same age and sex.

Device: Pentacam

Interventions

PentacamDEVICE

Pentacam will be used to measure the magnitude and axis orientation of anterior and posterior corneal astigmatism.

Normal people at the same age and sexPatients with keratoconus

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with keratoconus using the following criteria:
  • Specific diagnostic signs is asymmetric refractive errors with high progressive or irregular astigmatism, and elevated keratometry values, scissoring of the red reflex, Vogt striae, Fleischer rings, inferior or central steepening on topography with abnormal localized steepening .

You may not qualify if:

  • Unwillingness to participate in the study .
  • Corneal scarring.
  • Any ectatic conditions that were not explicitly keratoconus such as keratoglobus and pellucid marginal degeneration .
  • Previous ocular surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Rabinowitz YS. Keratoconus. Surv Ophthalmol. 1998 Jan-Feb;42(4):297-319. doi: 10.1016/s0039-6257(97)00119-7.

    PMID: 9493273BACKGROUND

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

February 23, 2018

First Posted

March 1, 2018

Study Start

October 1, 2019

Primary Completion

October 1, 2020

Study Completion

October 1, 2021

Last Updated

October 17, 2018

Record last verified: 2018-10