E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Will plan to investigate patients who would benefit from cataract surgery but whom have corneal scarring which would make surgery difficult. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10011044 |
E.1.2 | Term | Corneal scar |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective of our trial is to improve patient's visual acuity following cataract surgery. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The trial will end when 6 subjects have been treated and followed up for a minimum of one month after surgery. The end of the trial will therefore correspond to the last visit of the last subject. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |