KeratoconusNCT02485951
Central Versus Peripheral Air Injection for DALK (Deep Anterior Lamellar Keratoplasty)
A study testing Central air injection and Peripheral air injection in people with Keratoconus, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Different techniques of deep anterior lamellar keratoplasty (DALK) have been introduced to create a uniform recipient bed, thereby reducing complications, such as interface irregularity and opacification encountered with conventional lamellar keratoplasty. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Keratoconus
- What is being tested?
- Central air injection and Peripheral air injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteIran
- Study dates
- Jan 2014to Jun 2015
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with moderate (48 D < mean keratometry < 55 D) to advanced (mean keratometry ≥ 55 D or immeasurable keratometry) keratoconus were enrolled.
Who cannot join
- History of ocular surgery, concomitant ocular pathologies, such as vernal keratoconjunctivitis, cataract, glaucoma, and retinal abnormalities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Big-bubble Deep Anterior Lamellar Keratoplasty: Central Versus Peripheral Air Injection
Different techniques of deep anterior lamellar keratoplasty (DALK) have been introduced to create a uniform recipient bed, thereby reducing complications, such as interface irregularity and opacification encountered with conventional lamellar keratoplasty. The big-bubble technique provides a planned, safe, quick and consistent baring of Descemet membrane (DM) by injection of air deep into the stroma. Nevertheless, this technique has a long learning curve with a low success rate of big-bubble formation and a high rate of DM perforation when performed by surgeons in training. Different modifications to the original technique using intraoperative instruments such as corneal pachymetry, anterior segment optical coherence tomography (OCT), and femtosecond laser, have been used to increase the chances of achieving a successful DM detachment from the deep stroma by air injection. Even with these innovations, the rate of successful big-bubble formation did not reach 100%. Recently, the investigators described a modification to the original big-bubble DALK in which a 27-gauge needle was inserted into the stroma peripherally from the trephination site towards the limbus. The investigators found that air injection peripheral to the trephination can effectively and reproducibly separate the corneal stroma from the Descemet membrane (DM). This study was aimed to compare the success rate and complications of big-bubble DALK using central versus peripheral air injection performed by senior cornea fellows under the supervision of an experienced faculty member in an academic hospital.
- Conditions
- Keratoconus
- Being tested
- Central air injection, Peripheral air injection
- Keywords
- deep anterior lamellar keratoplasty, big-bubble technique, peripheral air injection, keratoconus
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central air injectionProcedure or surgery
Air was injected inside the trephination site in the central injection group.
Peripheral air injectionProcedure or surgery
Air was injected at the corneal periphery outside the trephination site.
| Study group | Role | What they receive |
|---|---|---|
| Central air injection | Active comparator | The needle was moved radially inside the trephination site and advanced to the central or paracentral cornea. Receives: Procedure: Central air injection |
| Peripheral air injection | Active comparator | The needle was inserted into the deep stroma from the trephination site and advanced into the peripheral cornea to approximately 1.5 mm anterior to the limbus. Receives: Procedure: Peripheral air injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of successful big-bubble formation
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startJan 2014
- Primary completionJun 2015
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
- Single blind
- Who is masked
- Participant
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sepehr Feizi, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485951
- Sponsor's protocol ID
- ShaheedBMU54
- Status last verified
- Jun 2015
- First submitted
- 13 Jun 2015
- Last updated
- 20 Apr 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Big-bubble Deep Anterior Lamellar Keratoplasty: Central Versus Peripheral Air Injection
- ClinicalTrials.gov ID
- NCT02485951
- Acronym / sponsor ID
- ShaheedBMU54
- Conditions
- Keratoconus
- Keywords
- deep anterior lamellar keratoplasty, big-bubble technique, peripheral air injection, keratoconus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jun 2015 (actual)
- First posted
- 30 Jun 2015 (estimated)
- 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.
Different techniques of deep anterior lamellar keratoplasty (DALK) have been introduced to create a uniform recipient bed, thereby reducing complications, such as interface irregularity and opacification encountered with conventional lamellar keratoplasty. The big-bubble technique provides a planned, safe, quick and consistent baring of Descemet membrane (DM) by injection of air deep into the stroma. Nevertheless, this technique has a long learning curve with a low success rate of big-bubble formation and a high rate of DM perforation when performed by surgeons in training. Different modifications to the original technique using intraoperative instruments such as corneal pachymetry, anterior segment optical coherence tomography (OCT), and femtosecond laser, have been used to increase the chances of achieving a successful DM detachment from the deep stroma by air injection. Even with these innovations, the rate of successful big-bubble formation did not reach 100%. Recently, the investigators described a modification to the original big-bubble DALK in which a 27-gauge needle was inserted into the stroma peripherally from the trephination site towards the limbus. The investigators found that air injection peripheral to the trephination can effectively and reproducibly separate the corneal stroma from the Descemet membrane (DM). This study was aimed to compare the success rate and complications of big-bubble DALK using central versus peripheral air injection performed by senior cornea fellows under the supervision of an experienced faculty member in an academic hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Central air injection | Active comparator | Procedure: Central air injectionThe needle was moved radially inside the trephination site and advanced to the central or paracentral cornea. |
| Peripheral air injection | Active comparator | Procedure: Peripheral air injectionThe needle was inserted into the deep stroma from the trephination site and advanced into the peripheral cornea to approximately 1.5 mm anterior to the limbus. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with moderate (48 D < mean keratometry < 55 D) to advanced (mean keratometry ≥ 55 D or immeasurable keratometry) keratoconus were enrolled.
Key exclusion criteria (1 listed)
- History of ocular surgery, concomitant ocular pathologies, such as vernal keratoconjunctivitis, cataract, glaucoma, and retinal abnormalities.
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 |
|---|---|---|
| Central air injectionAir was injected inside the trephination site in the central injection group. | Procedure or surgery | Central air injection |
| Peripheral air injectionAir was injected at the corneal periphery outside the trephination site. | Procedure or surgery | Peripheral air injection |
Primary outcome
The rate of successful big-bubble formation
Time frame: One year
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 20 Apr 2016.
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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.
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?
A study testing Central air injection and Peripheral air injection 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 1 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 20 Apr 2016. 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.
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?
The rate of successful big-bubble formation (time frame: One year). 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 20 Apr 2016.