Antisense Oligonucleotide Eye Drops Against IRS-1 to Treat Pathological Corneal Neovascularisation in Aniridia-Associated Keratopathy (Olisens-Aniridia)

Conditions

Corneal Neovascularization in Aniridia-associated Keratopathy

Brief summary

Relative change of corneal area covered by CoNV assessed by digital standardized slit lamp images and an independent reading center.

Detailed description

Visual acuity (BCVA) measured by ETDRS charts (transformed to logMAR), Glare visual acuity measured by ETDRS charts (transformed to logMAR), Vision related quality of life assessed by overall score of NEI-VFQ25 and overall score of Aniridia-Net questionnaire, Intraocular pressure measured by I Care or Goldmann applanation tonometry, reported as mmHg, Ocular Surface Staining measured by Oxford Grading Scale (Grades 0-5), Corneal Sensation measured by length of the nylon monofilament of Cochet-Bonnet esthesiometer when the applied pressure is noticed by the participant, Central Corneal Thickness measured by Scheimpflug Corneal Tomography (Pentacam) or Anterior Segment Optical Coherence Tomography (Casia-2), Vessel Morphometry measured by vessel thickness, vessel length, vessel regression, vessel recurrence, Quality of Life (Ocular Pain) assessed by overall score of Ocular Pain Asessment Survey (OPAS), Aniridia-Associated Keratopathy Grading measured by Lagali Aniridia Associated Kerathopathy Grading, Retinal adverse events (Optical Coherence Tomography), Active infectious keratitis or corneal ulceration assessed by slit lamp examination

Related papers

No related papers found yet.

Interventions

DRUGOLISENS 0

DRUG86 mg/ml

DRUGcollyre en solution en récipient unidose

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Relative change of corneal area covered by CoNV assessed by digital standardized slit lamp images and an independent reading center.	—

Secondary

Measure	Time frame
Visual acuity (BCVA) measured by ETDRS charts (transformed to logMAR), Glare visual acuity measured by ETDRS charts (transformed to logMAR), Vision related quality of life assessed by overall score of NEI-VFQ25 and overall score of Aniridia-Net questionnaire, Intraocular pressure measured by I Care or Goldmann applanation tonometry, reported as mmHg, Ocular Surface Staining measured by Oxford Grading Scale (Grades 0-5), Corneal Sensation measured by length of the nylon monofilament of Cochet-Bonnet esthesiometer when the applied pressure is noticed by the participant, Central Corneal Thickness measured by Scheimpflug Corneal Tomography (Pentacam) or Anterior Segment Optical Coherence Tomography (Casia-2), Vessel Morphometry measured by vessel thickness, vessel length, vessel regression, vessel recurrence, Quality of Life (Ocular Pain) assessed by overall score of Ocular Pain Asessment Survey (OPAS), Aniridia-Associated Keratopathy Grading measured by Lagali Aniridia Associated Kerathop	—

Measure

Time frame

Visual acuity (BCVA) measured by ETDRS charts (transformed to logMAR), Glare visual acuity measured by ETDRS charts (transformed to logMAR), Vision related quality of life assessed by overall score of NEI-VFQ25 and overall score of Aniridia-Net questionnaire, Intraocular pressure measured by I Care or Goldmann applanation tonometry, reported as mmHg, Ocular Surface Staining measured by Oxford Grading Scale (Grades 0-5), Corneal Sensation measured by length of the nylon monofilament of Cochet-Bonnet esthesiometer when the applied pressure is noticed by the participant, Central Corneal Thickness measured by Scheimpflug Corneal Tomography (Pentacam) or Anterior Segment Optical Coherence Tomography (Casia-2), Vessel Morphometry measured by vessel thickness, vessel length, vessel regression, vessel recurrence, Quality of Life (Ocular Pain) assessed by overall score of Ocular Pain Asessment Survey (OPAS), Aniridia-Associated Keratopathy Grading measured by Lagali Aniridia Associated Kerathop

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Countries

Germany

Outcome results

None listed