Advanced KeratoconusNCT01686906
Isolated Bowman Layer Graft for Reducing and Stabilizing Advanced Keratoconus
A study testing Bowman layer graft implantation in people with Advanced Keratoconus, run by Netherlands Institute for Innovative Ocular Surgery at 1 site in Netherlands.
Trial summary
To evaluate the efficacy of mid-stromal implantation of an isolated Bowman layer graft, to reduce and stabilize ectasia in eyes with advanced keratoconus Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Advanced Keratoconus
- What is being tested?
- Bowman layer graft implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2011to Dec 2020
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- •Advanced keratoconus
Who cannot join
- Further ophthalmic diseases
- History of ocular surgery
- Pregnancy, brest feeding
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Netherlands Institute for Innovative Ocular Surgery
Rotterdam, 3071 AA
About this study
Official title: Mid-stromal Isolated Bowman Layer Graft Implantation to Reduce and Stabilize Advanced Keratoconus
To evaluate the efficacy of mid-stromal implantation of an isolated Bowman layer graft, to reduce and stabilize ectasia in eyes with advanced keratoconus
- Conditions
- Advanced Keratoconus
- Being tested
- Bowman layer graft implantation
- Keywords
- Keratoconus, Bowman layer
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bowman layer graft implantationProcedure or surgery
For patients with progressive advanced keratoconus, a mid-stromal manual dissection is made and a donor isolated Bowman layer is positioned into the stromal pocket.
| Study group | Role | What they receive |
|---|---|---|
| Bowman layer graft implantation | Experimental | Not described Receives: Procedure: Bowman layer graft implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal power
Reduction and stabilizing of the corneal power after Bowman layer graft implantation
Measured: 2011-2020
Secondary outcomes (1)
Best corrected visual acuity
Measured: 2011-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2012 (estimated)
- Study startJan 2011
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Advanced 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Netherlands Institute for Innovative Ocular Surgery
- Sponsor type
- University, hospital or other
- Collaborators
- Amnitrans Eyebank Rotterdam
- Responsible party
- Sponsor
- Investigators
- Gerrit RJ Melles, MD, PhD, Principal investigator, Netherlands Institute for Innovative Ocular Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686906
- Sponsor's protocol ID
- NIIOS-BL-2012
- Status last verified
- Jan 2023
- First submitted
- 13 Sep 2012
- Last updated
- 12 Jan 2023
- Results posted
- No
Publications
van Dijk K, Liarakos VS, Parker J, Ham L, Lie JT, Groeneveld-van Beek EA, Melles GR. Bowman layer transplantation to reduce and stabilize progressive, advanced keratoconus. Ophthalmology. 2015 May;122(5):909-17. doi: 10.1016/j.ophtha.2014.12.005. Epub 2015 Jan 14.
PubMed 25596620van Dijk K, Parker J, Tong CM, Ham L, Lie JT, Groeneveld-van Beek EA, Melles GR. Midstromal isolated Bowman layer graft for reduction of advanced keratoconus: a technique to postpone penetrating or deep anterior lamellar keratoplasty. JAMA Ophthalmol. 2014 Apr 1;132(4):495-501. doi: 10.1001/jamaophthalmol.2013.5841.
PubMed 24557359Groeneveld-van Beek EA, Parker J, Lie JT, Bourgonje V, Ham L, van Dijk K, van der Wees J, Melles GR. Donor Tissue Preparation for Bowman Layer Transplantation. Cornea. 2016 Dec;35(12):1499-1502. doi: 10.1097/ICO.0000000000000905.
PubMed 27362885Parker JS, van Dijk K, Melles GR. Treatment options for advanced keratoconus: A review. Surv Ophthalmol. 2015 Sep-Oct;60(5):459-80. doi: 10.1016/j.survophthal.2015.02.004. Epub 2015 Mar 5.
PubMed 26077628van der Star L, van Dijk K, Vasiliauskaite I, Dapena I, Oellerich S, Melles GRJ. Long-Term Outcomes of Bowman Layer Inlay Transplantation for the Treatment of Progressive Keratoconus. Cornea. 2022 Sep 1;41(9):1150-1157. doi: 10.1097/ICO.0000000000002871. Epub 2021 Oct 5.
PubMed 34620767
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid-stromal Isolated Bowman Layer Graft Implantation to Reduce and Stabilize Advanced Keratoconus
- ClinicalTrials.gov ID
- NCT01686906
- Acronym / sponsor ID
- NIIOS-BL-2012
- Conditions
- Advanced Keratoconus
- Keywords
- Keratoconus, Bowman layer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Netherlands Institute for Innovative Ocular SurgeryUniversity, hospital or other
- Collaborators
- Amnitrans Eyebank Rotterdam
- Study start
- Jan 2011
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 18 Sep 2012 (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.
To evaluate the efficacy of mid-stromal implantation of an isolated Bowman layer graft, to reduce and stabilize ectasia in eyes with advanced keratoconus
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bowman layer graft implantation | Experimental | Procedure: Bowman layer graft implantation |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- •Advanced keratoconus
Key exclusion criteria (3 listed)
- Further ophthalmic diseases
- History of ocular surgery
- Pregnancy, brest feeding
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 |
|---|---|---|
| Bowman layer graft implantationFor patients with progressive advanced keratoconus, a mid-stromal manual dissection is made and a donor isolated Bowman layer is positioned into the stromal pocket. | Procedure or surgery | Bowman layer graft implantation |
Primary outcome
Corneal power
Time frame: 2011-2020
Reduction and stabilizing of the corneal power after Bowman layer graft implantation
1 secondary outcome
Best corrected visual acuity
Time frame: 2011-2020
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 12 Jan 2023.
- Background: PubMed 25596620van Dijk K, Liarakos VS, Parker J, Ham L, Lie JT, Groeneveld-van Beek EA, Melles GR. Bowman layer transplantation to reduce and stabilize progressive, advanced keratoconus. Ophthalmology. 2015 May;122(5):909-17. doi: 10.1016/j.ophtha.2014.12.005. Epub 2015 Jan 14.
- Background: PubMed 24557359van Dijk K, Parker J, Tong CM, Ham L, Lie JT, Groeneveld-van Beek EA, Melles GR. Midstromal isolated Bowman layer graft for reduction of advanced keratoconus: a technique to postpone penetrating or deep anterior lamellar keratoplasty. JAMA Ophthalmol. 2014 Apr 1;132(4):495-501. doi: 10.1001/jamaophthalmol.2013.5841.
- Background: PubMed 27362885Groeneveld-van Beek EA, Parker J, Lie JT, Bourgonje V, Ham L, van Dijk K, van der Wees J, Melles GR. Donor Tissue Preparation for Bowman Layer Transplantation. Cornea. 2016 Dec;35(12):1499-1502. doi: 10.1097/ICO.0000000000000905.
- Background: PubMed 26077628Parker JS, van Dijk K, Melles GR. Treatment options for advanced keratoconus: A review. Surv Ophthalmol. 2015 Sep-Oct;60(5):459-80. doi: 10.1016/j.survophthal.2015.02.004. Epub 2015 Mar 5.
- Background: PubMed 34620767van der Star L, van Dijk K, Vasiliauskaite I, Dapena I, Oellerich S, Melles GRJ. Long-Term Outcomes of Bowman Layer Inlay Transplantation for the Treatment of Progressive Keratoconus. Cornea. 2022 Sep 1;41(9):1150-1157. doi: 10.1097/ICO.0000000000002871. Epub 2021 Oct 5.
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.
Gerrit RJ Melles, MD, PhD principal investigator
Netherlands Institute for Innovative Ocular Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bowman layer graft implantation in people with Advanced Keratoconus, run by Netherlands Institute for Innovative Ocular Surgery at 1 site in Netherlands.
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 12 Jan 2023. 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 Netherlands. 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?
Corneal power (time frame: 2011-2020). 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 NCT01686906, which also lists 5 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 12 Jan 2023; AzTrials last refreshed its copy on 5 Nov 2026.