PENTACON Trial: Partial ENdothelial Trepanation in Addition to Anterior Lamellar Keratoplasty in keratoCONus
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Purpose
Rationale:
Keratoconus is a progressive, non-inflammatory corneal disease in which irregular refractive properties of the cornea result in loss of visual acuity. Treatment is aimed at improving vision, principally using (rigid) contact lenses. With progression of the disease non-correctable refractive abnormalities and/or corneal scars arise. For these advanced stages of keratoconus, a corneal transplant is the only treatment modality.
New surgical grafting modalities have been developed to create partial thickness grafts, according to the location of corneal pathology. For keratoconus, transplanting only the anterior corneal lamellae lowers long-term graft rejection rates. We utilize a method to enhance the safety of the grafting procedure while better visual outcomes are expected.
Objective:
To investigate the additional value of partial endothelial trepanation (PET) in an anterior lamellar keratoplasty (ALKP) procedure in terms of efficacy and safety in patients with keratoconus.
Study design:
A randomized controlled interventional trial
Study population:
Patients over 18 years old with keratoconus in whom contact lens correction is unsuccessful and who are not suitable for corneal crosslinking.
Intervention:
Patients will be randomly assigned to corneal grafting techniques; partial endothelial trepanation in addition to an anterior lamellar keratoplasty (i.e. the PET group) or a regular ALKP procedure.
Study outcomes:
Risk of per-operative perforation. Secondary, factors contributing to treatment safety and efficacy.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
There is no extra burden or risk associated with participation in this study. All measurements are part of normal clinical practice. Adequate experience is available with both surgical techniques. Study participation has no effect on donor selection. If partial endothelial trepanation (PET) is associated with lower complication rates and better visual outcomes, this might be beneficial in terms of morbidity.
| Condition | Intervention |
|---|---|
|
Keratoconus |
Procedure: PET Procedure: DALK |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Pentacon Trial: Partial ENdothelial Trepanation in Addition to Anterior Lamellar Keratoplasty in keratoCONus. A Prospective Multicenter Randomized Controlled Trial |
- Peroperative corneal perforation [ Time Frame: During Surgery. From start to closure of surgical procedure approx. 2h ] [ Designated as safety issue: Yes ]Peroperative corneal perforation is the biggest drawback of currently utilized grafting procedures (ALKP, 20-30%). Our new technique is believed to be safer, by reducing the number of corneal perforations during surgery. Corneal perforation necessitates converting the procedure to a full-thickness graft with a less favourable long term rejection profile.
- Best corrected visual acuity one year post op [ Time Frame: One year post-op ] [ Designated as safety issue: No ]To determine treatment efficacy visual acuity is assessed one year post-op.
- Manifest refraction one year post op [ Time Frame: One year post-op ] [ Designated as safety issue: No ]Manifest refraction can be grossly altered after corneal grafting procedures. To assess this effect, a manifest refraction one year post-op is obtained.
- Contact lens use (soft/rigid/scleral) or spectacle use [ Time Frame: one year post-op ] [ Designated as safety issue: No ]To assess the dependency on visual aids after corneal grafting. Residual irregular post-op corneal abnormalities can necessitate (rigid) contact lens wear.
- Self-rated improvement questionnaire [ Time Frame: One year post-op ] [ Designated as safety issue: No ]To assess patient satisfaction with treatment outcomes, such as visual acuity, residual refraction etc. This will be measured using the Visual Functioning Questionnaire-25 (Dutch edition).
- Corneal endothelial function one year post op [ Time Frame: One year post-op ] [ Designated as safety issue: Yes ]To assess cornealendothelial function as a measurement for corneal damage sustained during grafting procedure. Endothelial function plays a role in long term corneal decompensation issues.
- Graft rejection rate [ Time Frame: During one-year follow up period ] [ Designated as safety issue: Yes ]Lamellar grafting has proven to lower graft rejection rates. Any graft rejection (endothelial, stromal or epithelial) will be recorded en reported.
| Estimated Enrollment: | 80 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: PET
Partial endothelial trepanation in addition to anterior lamellar keratoplasty. The endothelium en Descemet are paracentrally and circular loosened, but some tissue bridges are left in place. This 'island' is able to mould to the healthy donor curvature. |
Procedure: PET
Partial Endothelial Trepanation in addition to an anterior lamellar keratoplasty
Other Name: Busin
|
|
Active Comparator: DALK
Conventional DALK grafting procedure where the Big Bubble technique is used according to Anwar et al.
|
Procedure: DALK
Conventional DALK grafting procedure, with Big Bubble technique according to Anwar et al.
Other Name: ALK
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age equal or above 18 years
keratoconus as defined and classified by
- presence of corneal thinning and protrusion on slit-lamp examination
- topographic criteria according to KISA% index (>100%)
- mean corneal curvature map
- decreased best corrected visual acuity due to corneal scarring or contact lens intolerance
Exclusion Criteria:
- prior corneal surgery, cross linking, refractive surgery or other treatment modalities
- (localized) corneal thickness < 200 µm
associated corneal endothelial disease on specular microscopy as defined by:
- <1500 endothelial cells per mm2
- polymegathism > 0.3
- pleomorphism < 0.6 (all are measurements of endothelial dysfunction)
- gross ophthalmic pathology surpassing keratoconus as cause of decreased visual acuity
- keratoconus-like disease (keratoglobus, pellucid marginal degeneration)
- associated corneal anomalies (microcornea, macrocornea, buphthalmos, Peters syndrome, ICE-syndrome etc.)
Contacts and Locations| Contact: Allegonda Van der Lelij, MD PhD | 0031 (0) 887556780 | a.vanderlelij@umcutrecht.nl |
| Contact: Robert Wisse, MD | 0031 (0) 887556780 | r.p.l.wisse@umcutrecht.nl |
| Netherlands | |
| University Medical Center Utrecht | Not yet recruiting |
| Utrecht, Netherlands, 3508 GA | |
| Contact: Robert Wisse, MD 0031 (0) 88 7556780 r.p.l.wisse@umcutrecht.nl | |
| Principal Investigator: Allegonda Van der Lelij, MD PhD | |
| Principal Investigator: | Allegonda Van der Lelij, MD PhD | UMC Utrecht |
More Information
No publications provided
| Responsible Party: | Dr. A. van der Lelij, Ophthalmologist, Department of Ophthalmology, Division of Surgical Specialties, UMC Utrecht |
| ClinicalTrials.gov Identifier: | NCT01145937 History of Changes |
| Other Study ID Numbers: | 30756.041.10 |
| Study First Received: | June 14, 2010 |
| Last Updated: | June 23, 2010 |
| Health Authority: | Netherlands: Central Committee on Research inv. Human Subjects (CCMO) |
Keywords provided by UMC Utrecht:
|
Keratoconus Corneal grafting Corneal transplantation Anterior Lamellar Keratoplasty |
Additional relevant MeSH terms:
|
Keratoconus Corneal Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 23, 2013