Implant 2 piece IOL device for rehabilitating patients with dry ARMD
Research type
Research Study
Full title
Proof of Concept trial for a double Intra-ocular Lens (IOL) implant for Visual Rehabilitation of Patients with dry Age Related Macular Degeneration (ARMD)
IRAS ID
110402
Contact name
Brendan Moriarty
Contact email
Sponsor organisation
See Again Europe Limited
ISRCTN Number
ISRCTN93069723
Research summary
Age Related Macular Degeneration (ARMD) is the leading cause of blindness in the western world. Many patients end up with a central scotoma (blind spot) which severely restricts their central vision. There has been a recent renewal in interest in implanting magnifying devices in suitable dry ARMD patients. In recent years Soleko has developed the IOL VIP system (Galilean telescope lens system) that in combination with a rehabilitation paragram has improved the vision in some dry ARMD sufferers (Ophthalmology 2007; 850-865). See Again Europe has designed a intra-ocular lens system specifically to improve the vision of some dry ARMD sufferers who have some remaining healthy macula. The device is designed to magnify and consistently and reproducibly divert the image to the healthy macula by offsetting the optical centres of the two lenses to produce a prismatic effect. From a clinical and operative perspective the procedure to implant the See Again Lens is equivalent to that of the IOL VIP device but with the potential advantage of focusing the image on the healthier area of the retina.
This Proof of Concept trial is on 7 patients using an established surgical procedure to improve the vision of patients with dry macular degeneration. The intent of the Proof of Concept is to screen dry ARMD patients to find the location of the healthy macula in the eye with worst vision, implant the device in 7 patients to divert the image to the healthier macula and identify if vision improvement has been established and to what degree and when.
Improvement will be judged by final best-corrected visual acuity (using ETDRS charts), reading magnification and reading distance at three months.
The results from the study will be statistically analysed by University College Dublin and used to justify a larger study in Ireland, UK and France.REC name
Yorkshire & The Humber - Leeds West Research Ethics Committee
REC reference
13/YH/0093
Date of REC Opinion
19 Jun 2013
REC opinion
Further Information Favourable Opinion