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Biosynthetic corneas – evaluation in humans

2009· article· en· W1482780962 on OpenAlexaff
Per Fagerholm, Neil Lagali, May Griffith

Bibliographic record

VenueActa Ophthalmologica · 2009
Typearticle
Languageen
FieldMedicine
TopicCorneal Surgery and Treatments
Canadian institutionsUniversity of Ottawa
Fundersnot available
KeywordsKeratoconusMedicineOphthalmologyCorneaSurgery

Abstract

fetched live from OpenAlex

Abstract Collagen‐based biosynthetic corneas, designed to mimic the extracellular matrix of the corneal stroma have been developed and extensively evaluated in animal models over the last 7 years. Human recombinant collagen type III (RHC III) was crosslinked with water‐soluble carbodiimides and fabricated into optically transparent corneal substitutes for transplantation. Following study approval of the Medical Product Agency, Sweden and the Human Ethics Committee, University of Linköping, Sweden, a Phase I study was initiated. 10 patients who were scheduled for corneal grafting were enrolled into the study. Nine had keratoconus and one had a deep scar following Pseudomonas keratitis. A central 6 mm diameter deep lamellar button was excised and was replaced by a 6.25 mm diameter 500 µm thick construct. Six overlying sutures were used to anchor the graft. Topical 0.1% dexametasone and chloramphenicol was used for the first 1 month postoperatively. The sutures were removed after 5‐7 weeks. The patients were followed clinically and evaluated for UCVA, BSCVA and VA with contact lenses. Corneal touch sensitivity (Cochet‐Bonnet) and tear production (Schirmer ) were tested. Photography, OCT (Visante), topography (Orbscan II) and in vivo confocal microscopy (Heidelberg) was documented. After 3 months all patients had stably epithelialized and implants were anchored by recipient keratocyte ingrowth. The mean BSCVA at 6 months (20/133) improved slightly at 12 months (20/90). The mean BCLCVA was 20/50 at 12 months and was notably better in younger patients (mean of 20/40 in the 5 youngest). One patient had BCLVA of 20/20 at 12 months. The mean central corneal thickness was stable between 3 and 12 months at about 400µm.The mean 5min Schirmer values were 20 ± 10mm in operated eyes and 17 ± 8 mm in fellow eyes. At 12 months the mean touch sensitivity was 25mm in operated eyes and 60mm in fellow eyes, which was the same as in penetrating grafts. In‐vivo confocal microscopy revealed the ingrowth of corneal nerves at the subbasal epithelium. We have shown for the first time that bioengineered collagen‐based corneal substitutes are fully compatible and promote regeneration of corneal cells. The 18 months follow‐up results will be presented aswell.

Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.

How this classification was reachedexpand

Full frame distilled prediction

Teacher imitation

Not calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.

metaresearch head score (Codex)0.000
metaresearch head score (Gemma)0.000
Version: codex-gemma-dda1882f352aValidation status: machine_predicted_unvalidated
Candidate categoriesInsufficient payload (model declined to judge)
Consensus categoriesnone
DomainCandidate signal: none · Consensus signal: none
Study designCandidate signal: Observational · Consensus signal: Observational
GenreCandidate signal: Empirical · Consensus signal: Empirical
Teacher disagreement score0.110
Threshold uncertainty score0.999

Codex and Gemma teacher scores by category

CategoryCodexGemma
Metaresearch0.0000.000
Meta-epidemiology (narrow)0.0000.000
Meta-epidemiology (broad)0.0000.000
Bibliometrics0.0000.000
Science and technology studies0.0000.000
Scholarly communication0.0000.000
Open science0.0000.000
Research integrity0.0000.000
Insufficient payload (model declined to judge)0.0020.000

Machine scores (provisional)

The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.

Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.

Opus teacher head0.072
GPT teacher head0.341
Teacher spread0.269 · how far apart the two teachers sit on this one work
Validation statusscore_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from it

Classification

machine, unvalidated

Machine predicted; a candidate call from one teacher head, not a consensus.

Study designObservational
Domainnot available
GenreEmpirical

How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".

Quick stats

Citations0
Published2009
Admission routes1
Has abstractyes

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