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Bowman layer transplantation for treatment of corneal contour deformations

Bowman layer transplantation for treatment of corneal contour deformations - BL transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55641
Enrollment
44
Registered
2017-07-17
Start date
2017-08-23
Completion date
Unknown
Last updated
2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Corneal contour deformation / corneal disease

Interventions

With the patient under local anesthesia, the corneal epithelium is removed. The Bowman graft is immersed in 70% ethanol for 30 seconds to remove remnant cellular material, thoroughly rinsed with bal
DORC International BV). The Bowman graft is then carefully positioned onto the host cornea, unfolded, and centered, using a rigid contact lens to transfer the tissue. Tissue is fixated spontaneously

Sponsors

Melles Hoornvlieskliniek Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Progressive keratoconus, or corneal contour deformation - Indication for a corneal transplant or surgery - 18 years and older - Agree to return for 1 day, 1 week , 1 month, 3 months, 6 months, 9 months, and 12 months post-procedure follow-up visits

Exclusion criteria

Exclusion criteria: - Concomitant ocular disease and/or a contraindication for this type of treatment (e.g. inflammation of the eye, uveitis etc), or any type of circumstances that may be expected to adversely affect the efficacy of the surgery. - Excluded from the study are patients with a severe corneal scarring, e.g. hydrops or contact lens induced opacifications - Severe diabetes - Unable to clearly understand the language used in the clinic (Dutch or English) - Inability to give informed consent for any reason - Pregnant or nursing

Design outcomes

Primary

MeasureTime frame
- Corneal curvature and pachymetry (thickness of the cornea) measured using a Pentacam apparatus and an Anterior Segment Optical Coherence Tomography apparatus (AS-OCT) (standard procedures).

Secondary

MeasureTime frame
- Endothelial cell density, as assessed by specular microscopy and confocal microscopy; - visual acuity, measured by the optometrist using a Snellen chart (standard procedure); - number of complications.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)