Will plan to investigate patients who would benefit from cataract surgery but whom have corneal scarring which would make surgery difficult. MedDRA version: 9.1 Level: LLT Classification code 10011044 Term: Corneal scar
Conditions
Interventions
Trade Name: Iohexol (OMNIPAQUE)
Product Name: Iohexol (OMNIPAQUE)
Pharmaceutical Form: Solution for injection
CAS Number: 66108-95-0
Other descriptive name: Iohexol, molecular formula C19H26I3N3O9
Co
Sponsors
University Hospitals Of Leicester NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: We will include patients with corneal opacities significant enough to interfere with a clear view of the internal structures of the eye necessary for cataract surgery but in whom cataract extraction offers a good chance of improved vision. These are the patients most likely to benefit from cataract extraction with this new technique. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: We would exclude patients with scarring so severe as to make cataract extraction unlikely to be of benefit for the patient. For these patients it would not be in their best interests to have surgery. The corneal clearing produced by Iohexol is only temporary so would not result in improved vision. Patients with a history of sensitivity to iodine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Patients with corneal scars often develop cataracts and associated deterioration of vision. The problem then is how to perform cataract surgery when the view for the surgeon through the cornea is poor. The limited view through the cornea may make modern cataract surgery, with phacoemulsification and miniature self-sealing incisions, impossible. Corneal scars are of high refractive index and if the tissue is impregnated with a solution that matches the refractive index of the scars, light scattering is reduced and they become transparent . We hope to temporarily render the cornea transparent and thus make it possible to safely perform small incision cataract surgery in eyes with scarred corneas. ;Secondary Objective: The secondary objective of our trial is to improve patient's visual acuity following cataract surgery.;Primary end point(s): The primary end point of this study is the maximum change in corneal clarity of the cornea after application of iohexol. We anticipate this will occur approximately 20 minutes after treatment and will be temporary. The changes in corneal clarity will be recorded photographically before surgery. The second endpoint is the change in visual acuity following cataract extraction using this technique. | — |
Countries
United Kingdom
Outcome results
None listed