Corneal EctasiaNCT04405882
Cornea Ectasia Excimer Laser Treatment
An observational study of Corneal Ectasia, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
Trial summary
To evaluate efficacy, safety, objective and subjective quality of vision after treatment of cornea ectasia with transepithelial topographic guided laser simultaneous Central Corneal Remodeling (CCR) and Cross-linking (CXL). Read more about this study
- Who is it for?
- Ages 19 to 66 years
- Conditions the study is for
- Corneal Ectasia
- What is being tested?
- topographic guided trans epithelial excimer laser
- Type of treatment
- Surgery or procedure
- How many people
- 8 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2019to 30 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eight eyes (2 right and 6 left eyes) of 8 patients, 5 male and 3 female (mean age 31.50±14.73, range 19 to 66 years), affected by cornea ectasia were enrolled in this study.
Who may be able to join
- keratoconus with moderate severity (Amsler-Krumeich stage I-II)
Who cannot join
- concomitant ocular disease
- concomitant systemic disease
- corneal opacities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Technique of Corneal Remodeling to Treat Ectasia
To evaluate efficacy, safety, objective and subjective quality of vision after treatment of cornea ectasia with transepithelial topographic guided laser simultaneous Central Corneal Remodeling (CCR) and Cross-linking (CXL).
Read the detailed description
Background To evaluate efficacy, safety, objective and subjective quality of vision after treatment of cornea ectasia performed with transepithelial topographic guided laser simultaneous Central Corneal Remodeling (CCR) and Cross-linking (CXL).
Methods In this retrospective study 8 eyes of 8 patients (mean age 31.50±14.73 years) affected by cornea ectasia underwent simultaneous CCR and CXL. Preoperative and 6 month postoperative uncorrected distance visual acuity (UDVC) and distance corrected visual acuity (DCVA) were measured using the Efficacy and Safety index. Objective and subjective quality of vision were evaluated preoperatively and 6 months postoperatively using corneal morphological irregularity index (CMI), National Eye Institute Visual Function NEI-VFQ25 and NEI-VFQ39 questionnaires.
- Conditions
- Corneal Ectasia
- Being tested
- topographic guided trans epithelial excimer laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topographic guided trans epithelial excimer laserProcedure or surgery
Also called corneal cross linking
In this retrospective study 8 eyes affected by cornea ectasia of 8 patients (mean age 31.50±14.73 years) underwent simultaneous CCR and CXL. Preoperative and 6 month postoperative uncorrected distance visual acuity (UDVC) and distance corrected visual acuity (DCVA) were measured using the Efficacy and Safety index. Objective and subjective quality of vision were respectively evaluated through preoperative and 6 month postoperative corneal morphological irregularity index (CMI), National Eye Institute Visual Function NEI-VFQ25 and NEI-VFQ39 questionnaires.
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of vision
uncorrected distance visual acuity (UDVC), distance corrected visual acuity (DCVA)
Measured: preoperatively
quality of vision
Efficacy and Safety index.
Measured: preoperatively
quality of vision
corneal morphological irregularity index (CMI)
Measured: preoperatively
quality of vision
uncorrected distance visual acuity (UDVC), distance corrected visual acuity (DCVA)
Measured: 6 months postoperatively
quality of vision
Efficacy and Safety index.
Measured: 6 months postoperatively
quality of vision
corneal morphological irregularity index (CMI)
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start1 Oct 2019
- Primary completion31 Oct 2019
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal EctasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bambino Gesù Hospital and Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Buzzonetti, Bambino Gesù Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04405882
- Sponsor's protocol ID
- L1
- Status last verified
- May 2020
- First submitted
- 18 May 2020
- Last updated
- 28 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Technique of Corneal Remodeling to Treat Ectasia
- ClinicalTrials.gov ID
- NCT04405882
- Acronym / sponsor ID
- L1
- Conditions
- Corneal Ectasia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Bambino Gesù Hospital and Research InstituteUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate efficacy, safety, objective and subjective quality of vision after treatment of cornea ectasia with transepithelial topographic guided laser simultaneous Central Corneal Remodeling (CCR) and Cross-linking (CXL).
Detailed description
Background To evaluate efficacy, safety, objective and subjective quality of vision after treatment of cornea ectasia performed with transepithelial topographic guided laser simultaneous Central Corneal Remodeling (CCR) and Cross-linking (CXL).
Methods In this retrospective study 8 eyes of 8 patients (mean age 31.50±14.73 years) affected by cornea ectasia underwent simultaneous CCR and CXL. Preoperative and 6 month postoperative uncorrected distance visual acuity (UDVC) and distance corrected visual acuity (DCVA) were measured using the Efficacy and Safety index. Objective and subjective quality of vision were evaluated preoperatively and 6 months postoperatively using corneal morphological irregularity index (CMI), National Eye Institute Visual Function NEI-VFQ25 and NEI-VFQ39 questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eight eyes (2 right and 6 left eyes) of 8 patients, 5 male and 3 female (mean age 31.50±14.73, range 19 to 66 years), affected by cornea ectasia were enrolled in this study.
Key inclusion criteria (1 listed)
- keratoconus with moderate severity (Amsler-Krumeich stage I-II)
Key exclusion criteria (3 listed)
- concomitant ocular disease
- concomitant systemic disease
- corneal opacities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topographic guided trans epithelial excimer laserAlso: corneal cross linkingIn this retrospective study 8 eyes affected by cornea ectasia of 8 patients (mean age 31.50±14.73 years) underwent simultaneous CCR and CXL. Preoperative and 6 month postoperative uncorrected distance visual acuity (UDVC) and distance corrected visual acuity (DCVA) were measured using the Efficacy and Safety index. Objective and subjective quality of vision were respectively evaluated through preoperative and 6 month postoperative corneal morphological irregularity index (CMI), National Eye Institute Visual Function NEI-VFQ25 and NEI-VFQ39 questionnaires. | Procedure or surgery | – |
Primary outcome
quality of vision
Time frame: preoperatively
uncorrected distance visual acuity (UDVC), distance corrected visual acuity (DCVA)
quality of vision
Time frame: preoperatively
Efficacy and Safety index.
quality of vision
Time frame: preoperatively
corneal morphological irregularity index (CMI)
quality of vision
Time frame: 6 months postoperatively
uncorrected distance visual acuity (UDVC), distance corrected visual acuity (DCVA)
quality of vision
Time frame: 6 months postoperatively
Efficacy and Safety index.
quality of vision
Time frame: 6 months postoperatively
corneal morphological irregularity index (CMI)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2020.
- Individual participant dataSharing planned: No
Related trials for Corneal Ectasia
RecruitingObservational study
A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia
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Corneal Crosslinking for Treatment of Progressive Keratoconus or Corneal Ectasia
Keratoconus, Corneal Ectasia
RecruitingObservational study
Corneal Elastography and Patient Specific Modeling
Cornea; Ectasia, Refractive Errors
Not yet recruitingPhase 4
Outcomes of CTAK Surgery
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RecruitingPhase 3
Comparison of Epi-ON Corneal Collagen Crosslinking Performed Using an 18-Minute UVA Exposure vs. a 24-Minute UVA Exposure on Eyes With Ectatic Corneal Diseases
Keratoconus, Ectasia of Cornea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Corneal Ectasia, run by Bambino Gesù Hospital and Research Institute at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of vision (time frame: preoperatively). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2020.