CClinicalTrials.gg
CompletedNCT01411384Updated Feb 22, 2012

Evaluation of Corneal Hysteresis and Corneal Resistance Factor After Corneal Cross-linking for Keratoconus

An interventional study of Corneal collagen cross-linking and Ocular Response Analyzer (ORA) in Progressive Keratoconus, sponsored by Democritus University of Thrace. Completed. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2012-02-22.

Sponsored by Democritus University of Thrace · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Non-randomized
Ages
15 Years and older
Sex
All
01

Study summary

This study attempts to compare Corneal Hysteresis (CH) and Corneal Resistance Factor (CRF) in a series of keratoconic eyes before and after Corneal collagen cross-linking (CXL). Furthermore, among the objectives of the study is to reveal correlations between CH and CRF and a series of corneal indexes like the Corneal Thickness (CT), mean keratometry (Km) and corneal astigmatism (Astig).

The study adhered to the tenets of the Declaration of Helsinki and written informed consent was given by all participants. The study was conducted at the Eye Institute of Thrace (ΕΙΤ), in Alexandroupolis, Greece. EΙΤ is a Democritus University research institute focusing primarily on the conditions of the anterior segment of the eye.

Participants were recruited from the Outpatients Cornea service of the EIT in a consecutive if eligible basis. Fifty (50) eyes of thirty (30) patients with keratoconus were recruited for the sake of the study and formed the keratoconus group (KG). Eligible subjects for the keratoconus group had to present progressive keratoconus in consecutive corneal topographies, changes in refractive power, and deterioration of the visual acuity within a period of two years. Exclusion criteria included glaucoma, glaucoma suspicion, and intraocular pressure (IOP) lowering drugs administration. Further to glaucoma, exclusion criteria included central corneal thickness (CCT) less than 400μm, K-readings more than 60D, a history of herpetic keratitis, corneal scarring, severe eye dryness, pregnancy or nursing, current corneal infection, or underlying autoimmune disease.

Fifty (50) eyes of fifty (50) non-keratoconic, age-matched, individuals who visited our outpatient service formed the control group (CG). Further to keratoconus, and a spherical equivalent error above 3D, the same exclusion criteria applied to the control group members, as well. All participants wearing contact lenses were instructed to discontinue contact lens wear at least a month before measurements.

CRF and CH parameters were obtained while the patient was sitting on a chair in front of the Ocular Response Analyzer (ORA; Reichert Ophthalmic Instruments, Buffalo, NY, USA) device. Upon successful fixation of the patient's eye on a red blinking target, the operator activated the device. An air puff was released by a non-contact probe, which scanned the central area of the eye and sent a signal to the ORA. In brief, the air puff causes the cornea to move inward, past applanation, and into slight concavity. After milliseconds, the air pumps shut off, the pressure decreases, and the cornea begins to return in its normal state. The system monitors the entire process and measures two pressure values, which are determined from the inward and outward applanation processes. The aforementioned measuring procedure enables the determination of CH which is related to the viscoelastic structure of the corneal tissue, and is calculated as the difference between the two pressure values at the two applanation processes, and CRF which is indicative of the overall resistance of the cornea and is calculated as a linear function of the two pressures associated with the two applanation. In order to ensure accurate results, ORA was done four times for each eye, by the same operator. Signals that differ significantly in appearance from the other signals from the same eye were deleted.

The same surgical procedure was applied to all keratoconus patients that included: Instillation of proparacaine hydrochloride 0.5% drops for topical anaesthesia, application of a sponge saturated with 10% alcohol to the central cornea for 30 seconds and subsequent de-epithelialization by means of a hockey knife. Following de-epithelialization, a mixture of 0.1% riboflavin in 20% Dextran solution was instilled to the cornea for 30 minutes (2 drops every 2 minutes) prior to the irradiation, until the stroma was completely penetrated and aqueous was stained yellow. The ultraviolet A (UVA) radiation source that was used is UV-XTM (IROC AG, Zurich, Switzerland). In details, an 8.0mm diameter of central cornea was irradiated for 30 minutes by UVA light with a wavelength of 370nm and an irradiance of 3mW/cm2. Instillation of riboflavin drops (1 drop every 2 minutes) was continued during irradiation, as well, in order to sustain the necessary concentration of the riboflavin. Moreover, balanced salt solution (BSS) was applied every 6 minutes to moisten the cornea.

After treatment all patients were prescribed topical ofloxacin drops qid, fluorometholone qid and diclofenac nitrate qid, accompanied by frequent instillation of artificial tears. Soft therapeutic lens was applied until complete re-epithelialization of the cornea was detected. Follow up visits were performed on the 1st day, 7th day, 1st, 3rd, 6th and 12th month after the operation.

02

Conditions studied

  • Progressive Keratoconus

Browse trials for

Keywords

  • Keratoconus (KC)
  • Corneal collagen cross-linking (CXL)
  • Corneal hysteresis (CH)
  • Corneal resistance factor (CRF)
  • Ocular Response Analyzer (ORA)
03

In context

Keratoconus

307 studies on the registry are indexed under Keratoconus; 56 are open to participants now.

This study's enrollment of 80 is above the median of 40 across 203 interventional studies indexed under Keratoconus.

Browse Keratoconus studies →

Lead sponsor

Democritus University of Thrace is the lead sponsor of 70 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
15 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Progressive keratoconus in consecutive corneal topographies
  • Changes in refractive power
  • Deterioration of the visual acuity within a period of two years

Exclusion criteria

Exclusion Criteria:

  • Glaucoma
  • Glaucoma suspicion
  • Intraocular pressure lowering drugs administration
  • Central Corneal Thickness less than 400μm
  • K-readings more than 60D
  • History of herpetic keratitis
  • Corneal scarring
  • Severe eye dryness
  • Pregnancy
  • Nursing
  • Current corneal infection
  • Underlying autoimmune disease
05

Study design

Phase
Not applicable
Allocation
Non-randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Interventions

  • ProcedureCorneal collagen cross-linking

    The same surgical procedure was applied to all keratoconus patients that included: Instillation of proparacaine hydrochloride 0.5% drops for topical anaesthesia, application of a sponge saturated with 10% alcohol to the central cornea for 30 seconds and subsequent de-epithelialization. Following de-epithelialization, a mixture of 0.1% riboflavin in 20% Dextran solution was instilled to the cornea for 30 minutes (2 drops every 2 minutes) prior to the irradiation, until the stroma was completely penetrated and aqueous was stained yellow. An 8.0mm diameter of central cornea was irradiated for 30 minutes by UVA light with a wavelength of 370nm and an irradiance of 3mW/cm2. Instillation of riboflavin drops (1 drop every 2 minutes) was continued during irradiation. Balanced salt solution (BSS) was applied every 6 minutes to moisten the cornea.

  • DeviceOcular Response Analyzer (ORA)

    An air puff is released by a non-contact probe, which scanned the central area of the eye and send a signal to the ORA device. The air puff causes the cornea to move inward, past applanation, and into slight concavity. After milliseconds, the air pumps shut off, the pressure decreases, and the cornea begins to return in its normal state. The system monitors the entire process and measures two pressure values, which are determined from the inward and outward applanation processes. The aforementioned measuring procedure enables the determination of Corneal Hysteresis and Corneal Resistance Factor.

06

What researchers measure

Primary outcomes

  1. Change from baseline in Corneal Hysteresis (CH)

    Time frame: at 3rd, 6th and 12th month postoperatively

  2. Change from baseline in Corneal Resistance Factor (CRF)

    Time frame: at 3rd, 6th and 12th month postoperatively

Secondary outcomes

  1. Change from baseline in Average keratometry (Km)

    Time frame: at 3rd, 6th and 12th month postoperatively

  2. Change from baseline in Corneal Thickness (CT)

    Time frame: at 3rd, 6th and 12th month postoperatively

  3. Change from baseline in Corneal Astigmatism (Astig.)

    Time frame: at 3rd, 6th and 12th month postoperatively

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01411384
Lead sponsor
Democritus University of Thrace
First posted
Aug 8, 2011
Start date
Apr 2008
Primary completion
Apr 2009
Completion
Apr 2010
Last update
Feb 22, 2012

Study contacts

Georgios Labiris, MD, PhD
principal investigator · Democritus University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion