KeratoconusPhase 2/3NCT04130334
Effects of Corneal Anatomical Match Between Donor and Recipient During DALK Surgery on Final Visual and Refractive Outcomes in Patients With KCN
A Phase 2/3 study testing After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea and : After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea in people with Keratoconus, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Patients with KCN who undergo cornea transplantation divided to 2 groups: Group1: After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea Group 2: After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of… Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratoconus
- What is being tested?
- After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea and : After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteIran
- Study dates
- 1 Jun 2018to 1 Mar 2020
- Phase
- Phase 2/3
- 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 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients with KCN who undergo DALK surgery
Who cannot join
- Penetrating Keratoplasty surgery
- Other corneal diseases
- dystrophies
- Corneal graft rejection
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Ophthalmic Research Center
Tehran
Sepehr Feizi, MD, 009822591616, labbafi@hotmail.com
About this study
Official title: Effects of Corneal Anatomical Match Between Donor and Recipient During DALK Surgery on Final Visual and Refractive Outcomes in Patients With KCN: a Clinical Trial
Patients with KCN who undergo cornea transplantation divided to 2 groups:
Group1: After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea Group 2: After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea After suture removal, best corrected visual acuity, refractive error, corneal keratometry, irregularity of corneal surface and high order aberration of two groups will compare
- Conditions
- Keratoconus
- Being tested
- After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea, : After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient corneaProcedure or surgery
After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea
: After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient corneaProcedure or surgery
: After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea
| Study group | Role | What they receive |
|---|---|---|
| horizontal meridian of donor's cornea sutured to horizontal | Active comparator | horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea Receives: Procedure: After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea |
| horizontal meridian of donor's cornea sutured to vertical | Active comparator | horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea Receives: Procedure: : After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
Snellen chart
Measured: 14 months
graft astigmatism
Topography
Measured: 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2019
- Study start1 Jun 2018
- Primary completion1 Jun 2019
- Study completion1 Mar 2020 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04130334
- Sponsor's protocol ID
- 10000
- Status last verified
- May 2019
- First submitted
- 7 Oct 2019
- Last updated
- 17 Oct 2019
- 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 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Corneal Anatomical Match Between Donor and Recipient During DALK Surgery on Final Visual and Refractive Outcomes in Patients With KCN: a Clinical Trial
- ClinicalTrials.gov ID
- NCT04130334
- Acronym / sponsor ID
- 10000
- Conditions
- Keratoconus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Mar 2020 (estimated)
- First posted
- 17 Oct 2019 (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.
Patients with KCN who undergo cornea transplantation divided to 2 groups:
Group1: After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea Group 2: After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea After suture removal, best corrected visual acuity, refractive error, corneal keratometry, irregularity of corneal surface and high order aberration of two groups will compare
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| horizontal meridian of donor's cornea sutured to horizontal | Active comparator | Procedure: After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient corneahorizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea |
| horizontal meridian of donor's cornea sutured to vertical | Active comparator | Procedure: : After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient corneahorizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with KCN who undergo DALK surgery
Key exclusion criteria (4 listed)
- Penetrating Keratoplasty surgery
- Other corneal diseases
- dystrophies
- Corneal graft rejection
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 |
|---|---|---|
| After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient corneaAfter mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea | Procedure or surgery | horizontal meridian of donor's cornea sutured to horizontal |
| : After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea: After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea | Procedure or surgery | horizontal meridian of donor's cornea sutured to vertical |
Primary outcome
Best corrected visual acuity
Time frame: 14 months
Snellen chart
graft astigmatism
Time frame: 14 months
Topography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea and : After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea in people with Keratoconus, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 4 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 17 Oct 2019. 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 Iran. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sepehr Feizi, MD (009822591616, labbafi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity (time frame: 14 months). The study lists 2 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 17 Oct 2019.