KeratoconusPhase 3DALKNCT00887900
Deep Anterior Lamellar Keratoplasty (DALK)
A Phase 3 study testing Deep anterior lamellar keratoplasty (DALK) and Penetrated keratoplasty in people with Keratoconus, run by Hospital Oftalmologico de Brasilia at 1 site in Brazil.
Trial summary
The purpose of this study is to report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique. 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 (DALK) and Penetrated keratoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2006to Dec 2008
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- keratoconus
Who cannot join
- central endothelial cell count less than 2000 cells/mm2
- glaucoma or intraocular pressure greater than 21 mmHg
- amblyopia
- retinal abnormalities
- diabetes mellitus
- steroid or immunosuppressive treatment
- connective tissue diseases
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Oftalmologico de Brasília
Brasília, Federal District, 70200670
About this study
Official title: Deep Anterior Lamellar Keratoplasty by Big-Bubble Technique: Results and Complications
The purpose of this study is to report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.
Read the detailed description
Purpose: To report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.
Methods: Thirty four unselected consecutive patients were submitted to DALK big-bubble technique. Intraoperative and postoperative complications, postoperative uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), spherical equivalent (SE), corneal topography, and endothelial cell density were evaluated. All patients were followed for at least 6 months.
- Conditions
- Keratoconus
- Being tested
- Deep anterior lamellar keratoplasty (DALK), Penetrated keratoplasty
- Keywords
- lamellar keratoplasty, keratoconus, penetrated keratoplasty, Visual acuity
- 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 keratoplasty (DALK)Procedure or surgery
Also called GROUP 1: DALK
Deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.
Penetrated keratoplastyProcedure or surgery
Also called GROUP 2: PK
Regular corneal transplant using the penetrated keratoplasty technique
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Submitted to deep anterior lamellar keratoplasty (DALK) using the big-bubble technique. Receives: Procedure: Deep anterior lamellar keratoplasty (DALK) |
| 2 | Active comparator | Submitted to regular penetrating keratoplasty Receives: Procedure: Penetrated keratoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
To report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2009 (estimated)
- Study startJan 2006
- Primary completionDec 2007
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Oftalmologico de Brasilia
- Sponsor type
- University, hospital or other
- Investigators
- PATRICK F TZELIKIS, PhD, MD, Principal investigator, Federal University of Minas Gerais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887900
- Sponsor's protocol ID
- DALK
- Acronym
- DALK
- Status last verified
- Apr 2009
- First submitted
- 23 Apr 2009
- Last updated
- 24 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tan DT, Parthasarathy A. Deep anterior lamellar keratoplasty for keratoconus. Cornea. 2007 Sep;26(8):1025; author reply 1025-6. doi: 10.1097/ICO.0b013e31805771e3. No abstract available.
PubMed 17721317Vajpayee RB, Tyagi J, Sharma N, Kumar N, Jhanji V, Titiyal JS. Deep anterior lamellar keratoplasty by big-bubble technique for treatment corneal stromal opacities. Am J Ophthalmol. 2007 Jun;143(6):954-957. doi: 10.1016/j.ajo.2007.02.036. Epub 2007 Apr 16.
PubMed 17434435Ardjomand N, Hau S, McAlister JC, Bunce C, Galaretta D, Tuft SJ, Larkin DF. Quality of vision and graft thickness in deep anterior lamellar and penetrating corneal allografts. Am J Ophthalmol. 2007 Feb;143(2):228-235. doi: 10.1016/j.ajo.2006.10.043. Epub 2006 Nov 30.
PubMed 17258522Tzelikis PF, Santos JD, Garcez RC, Akaishi L. [Deep anterior lamellar keratoplasty by big-bubble technique]. Arq Bras Oftalmol. 2011 Nov-Dec;74(6):435-40. doi: 10.1590/s0004-27492011000600011. Portuguese.
PubMed 22331118
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Anterior Lamellar Keratoplasty by Big-Bubble Technique: Results and Complications
- ClinicalTrials.gov ID
- NCT00887900
- Acronym / sponsor ID
- DALK / DALK
- Conditions
- Keratoconus
- Keywords
- lamellar keratoplasty, keratoconus, penetrated keratoplasty, Visual acuity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hospital Oftalmologico de BrasiliaUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 24 Apr 2009 (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.
The purpose of this study is to report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.
Detailed description
Purpose: To report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.
Methods: Thirty four unselected consecutive patients were submitted to DALK big-bubble technique. Intraoperative and postoperative complications, postoperative uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), spherical equivalent (SE), corneal topography, and endothelial cell density were evaluated. All patients were followed for at least 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Deep anterior lamellar keratoplasty (DALK)Submitted to deep anterior lamellar keratoplasty (DALK) using the big-bubble technique. |
| 2 | Active comparator | Procedure: Penetrated keratoplastySubmitted to regular penetrating keratoplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- keratoconus
Key exclusion criteria (7 listed)
- central endothelial cell count less than 2000 cells/mm2
- glaucoma or intraocular pressure greater than 21 mmHg
- amblyopia
- retinal abnormalities
- diabetes mellitus
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 keratoplasty (DALK)Also: GROUP 1: DALKDeep anterior lamellar keratoplasty (DALK) using the big-bubble technique. | Procedure or surgery | 1 |
| Penetrated keratoplastyAlso: GROUP 2: PKRegular corneal transplant using the penetrated keratoplasty technique | Procedure or surgery | 2 |
Primary outcome
To report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.
Time frame: 12 months
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 24 Apr 2009.
- Results publication: PubMed 17721317Tan DT, Parthasarathy A. Deep anterior lamellar keratoplasty for keratoconus. Cornea. 2007 Sep;26(8):1025; author reply 1025-6. doi: 10.1097/ICO.0b013e31805771e3. No abstract available.
- Results publication: PubMed 17434435Vajpayee RB, Tyagi J, Sharma N, Kumar N, Jhanji V, Titiyal JS. Deep anterior lamellar keratoplasty by big-bubble technique for treatment corneal stromal opacities. Am J Ophthalmol. 2007 Jun;143(6):954-957. doi: 10.1016/j.ajo.2007.02.036. Epub 2007 Apr 16.
- Results publication: PubMed 17258522Ardjomand N, Hau S, McAlister JC, Bunce C, Galaretta D, Tuft SJ, Larkin DF. Quality of vision and graft thickness in deep anterior lamellar and penetrating corneal allografts. Am J Ophthalmol. 2007 Feb;143(2):228-235. doi: 10.1016/j.ajo.2006.10.043. Epub 2006 Nov 30.
- Derived from this study: PubMed 22331118Tzelikis PF, Santos JD, Garcez RC, Akaishi L. [Deep anterior lamellar keratoplasty by big-bubble technique]. Arq Bras Oftalmol. 2011 Nov-Dec;74(6):435-40. doi: 10.1590/s0004-27492011000600011. Portuguese.
- PUBMEDLink provided by the sponsor.
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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.
PATRICK F TZELIKIS, PhD, MD principal investigator
Federal University of Minas Gerais
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Deep anterior lamellar keratoplasty (DALK) and Penetrated keratoplasty in people with Keratoconus, run by Hospital Oftalmologico de Brasilia at 1 site in Brazil.
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 7 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 24 Apr 2009. 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 Brazil. 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 phase mean?
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?
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?
To report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00887900, which also lists 4 linked publications.
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 24 Apr 2009.