KeratoconusNCT04430244
Deep Anterior Lamellar Keratoplasty Using Dehydrated Versus Standard Organ Culture Stored Donor Corneas
A study testing Deep anterior lamellar keratoplasty in people with Keratoconus, run by Istituto Internazionale di Ricerca e Formazione in Oftalmologia at 1 site in Italy.
Trial summary
The objective of this study is to assess the outcomes between deep anterior lamellar keratoplasty using dehydrated versus standard organ culture stored donor corneas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Keratoconus
- What is being tested?
- Deep anterior lamellar keratoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 17 Jun 2020to May 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Keratoconus
- Surgical candidates for deep anterior lamellar keratoplasty
Who cannot join
- Ocular comorbidities other than cataract (ie. visual significant optic nerve or macular disease)
- Previous corneal transplantations or other ocular surgeries except uncomplicated cataract surgery
- Inability to comply with study protocol or participate in follow-up visits
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Ospedali Privati Forlì "Villa Igea"
Forlì, Emilia-Romagna, 47122
Massimo Busin, MD, mbusin@yahoo.com
Massimo Busin, MD
About this study
Official title: Deep Anterior Lamellar Keratoplasty Using Dehydrated Versus Standard Organ Culture Stored Donor Corneas: A Randomized Controlled Trial
The objective of this study is to assess the outcomes between deep anterior lamellar keratoplasty using dehydrated versus standard organ culture stored donor corneas.
Read the detailed description
Keratoconus is a common corneal disease characterized by progressive thinning and steepening resulting in significant visual impairment. With improved instrumentation and corneal imaging technology, deep anterior keratoplasty has been recognized as the preferred primary operative technique for cases of keratoconus requiring corneal transplantation.
Since corneas preserved through organ culture remain viable only for up to 4 weeks, techniques that can extend storage of corneas have been explored.
The objective of this study is to assess the outcomes between deep anterior lamellar keratoplasty using dehydrated versus standard organ culture stored donor corneas.
- Conditions
- Keratoconus
- Being tested
- Deep anterior lamellar keratoplasty
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep anterior lamellar keratoplastyProcedure or surgery
Deep anterior lamellar keratoplasty using dehydrated corneas
Deep anterior lamellar keratoplastyProcedure or surgery
Deep anterior lamellar keratoplasty using standard organ culture stored corneas
| Study group | Role | What they receive |
|---|---|---|
| DALK using Dehydrated Corneas | Experimental | Corneal transplantation of anterior lamellar grafts from dehydrated corneas. Receives: Procedure: Deep anterior lamellar keratoplasty |
| DALK using Standard Organ Culture Stored Corneas | Active comparator | Corneal transplantation of anterior lamellar grafts from standard organ culture stored corneas. Receives: Procedure: Deep anterior lamellar keratoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in best spectacle-corrected visual acuity
Measured as the difference in best spectacle-corrected visual acuity preoperative, 6 and 12 months postoperatively using ETDRS chart
Measured: Preoperatively; and 6 and 12 months postoperatively
Secondary outcomes (6)
Change in astigmatism
Topographic astigmatism (Diopters) is measured using anterior segment optical coherence tomography (CASIA)
Measured: Preoperatively; and 6 and 12 months postoperatively
Change in Thinnest-point pachymetry
Thinnest-point pachymetry values (um) are measured using anterior segment optical coherence tomography (CASIA)
Measured: Preoperatively; and 6 and 12 months postoperatively
Change in endothelial cell density
Measured using noncontact specular microscopy
Measured: Preoperatively; and 6 and 12 months postoperatively
Incidence of graft rejection
Clinically assessed during postoperative examinations
Measured: 6 and 12 months postoperatively
Incidence of graft failure
Clinically assessed during postoperative examinations
Measured: 6 and 12 months postoperatively
Corneal donor loss due to preparation
Based on intraoperative assessment of corneas unusable for corneal transplantation
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2020
- Study start17 Jun 2020
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for KeratoconusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Internazionale di Ricerca e Formazione in Oftalmologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Massimo Busin, MD, Principal investigator, Università degli Studi di Ferrara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04430244
- Sponsor's protocol ID
- 2020001
- Status last verified
- Jul 2020
- First submitted
- 10 Jun 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Anterior Lamellar Keratoplasty Using Dehydrated Versus Standard Organ Culture Stored Donor Corneas: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04430244
- Acronym / sponsor ID
- 2020001
- Conditions
- Keratoconus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Istituto Internazionale di Ricerca e Formazione in OftalmologiaUniversity, hospital or other
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 12 Jun 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.
The objective of this study is to assess the outcomes between deep anterior lamellar keratoplasty using dehydrated versus standard organ culture stored donor corneas.
Detailed description
Keratoconus is a common corneal disease characterized by progressive thinning and steepening resulting in significant visual impairment. With improved instrumentation and corneal imaging technology, deep anterior keratoplasty has been recognized as the preferred primary operative technique for cases of keratoconus requiring corneal transplantation.
Since corneas preserved through organ culture remain viable only for up to 4 weeks, techniques that can extend storage of corneas have been explored.
The objective of this study is to assess the outcomes between deep anterior lamellar keratoplasty using dehydrated versus standard organ culture stored donor corneas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DALK using Dehydrated Corneas | Experimental | Procedure: Deep anterior lamellar keratoplastyCorneal transplantation of anterior lamellar grafts from dehydrated corneas. |
| DALK using Standard Organ Culture Stored Corneas | Active comparator | Procedure: Deep anterior lamellar keratoplastyCorneal transplantation of anterior lamellar grafts from standard organ culture stored corneas. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Keratoconus
- Surgical candidates for deep anterior lamellar keratoplasty
Key exclusion criteria (3 listed)
- Ocular comorbidities other than cataract (ie. visual significant optic nerve or macular disease)
- Previous corneal transplantations or other ocular surgeries except uncomplicated cataract surgery
- Inability to comply with study protocol or participate in follow-up visits
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 |
|---|---|---|
| Deep anterior lamellar keratoplastyDeep anterior lamellar keratoplasty using dehydrated corneas | Procedure or surgery | DALK using Dehydrated Corneas |
| Deep anterior lamellar keratoplastyDeep anterior lamellar keratoplasty using standard organ culture stored corneas | Procedure or surgery | DALK using Standard Organ Culture Stored Corneas |
Primary outcome
Change in best spectacle-corrected visual acuity
Time frame: Preoperatively; and 6 and 12 months postoperatively
Measured as the difference in best spectacle-corrected visual acuity preoperative, 6 and 12 months postoperatively using ETDRS chart
6 secondary outcomes
Change in astigmatism
Time frame: Preoperatively; and 6 and 12 months postoperatively
Change in Thinnest-point pachymetry
Time frame: Preoperatively; and 6 and 12 months postoperatively
Change in endothelial cell density
Time frame: Preoperatively; and 6 and 12 months postoperatively
Incidence of graft rejection
Time frame: 6 and 12 months postoperatively
Incidence of graft failure
Time frame: 6 and 12 months postoperatively
Corneal donor loss due to preparation
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
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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.
Massimo Busin, MD principal investigator
Università degli Studi di Ferrara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Deep anterior lamellar keratoplasty in people with Keratoconus, run by Istituto Internazionale di Ricerca e Formazione in Oftalmologia 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 2 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: status not confirmed, as of the sponsor's last update on 7 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Massimo Busin, MD (+393473448343, mbusin@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in best spectacle-corrected visual acuity (time frame: Preoperatively; and 6 and 12 months postoperatively). 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 7 Jul 2020.