Implant two piece intra-ocular lens system for treating dry age-related macular degeneration
| ISRCTN | ISRCTN93069723 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93069723 |
| Secondary identifying numbers | See Again 100 001 |
- Submission date
- 12/11/2012
- Registration date
- 16/11/2012
- Last edited
- 06/04/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Age-related macular degeneration (ARMD) is an eye condition that causes loss of central vision, usually in both eyes. There are two main types: dry ARMD and wet ARMD. Dry ARMD develops when the part of the eye responsible for central vision (the macula) is damaged by a build-up of deposits and is unable to function as effectively. There has been a recent renewal in interest in treating ARMD with lens implantation, where the lens of the eye is removed and replaced with an artificial lens designed to improve central vision. In recent years Soleko has developed the IOL VIP intraocular lens that in combination with a rehabilitation program has improved vision in ARMD patients. See Again Europe has designed an intraocular lens to improve the vision of ARMD patients who have remaining healthy macula. From a clinical 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 macula. The aim of this study is to evaluate the performance of the See Again Lens device to improve vision in patients with dry ARMD.
Who can participate?
Patients with significant stable dry ARMD
What does the study involve?
The eye’s natural lens is replaced with a two-lens system that magnifies and diverts the image to a healthy part of the macula. The implantation procedure is performed under local anaesthetic and is expected to take 45 minutes. Eye tests are carried out within 24 hours of the implantation procedure and 2, 4, 8 and 12 weeks and 3 months later.
What are the possible benefits and risks of participating?
It is anticipated that patients’ vision will improve and achieve a two-line improvement as judged by standard eye test charts. The procedure is similar to a cataract operation and has the same risks as this routinely performed implantation.
Where is the study run from?
The study will be conducted locally as convenient for the patient. It will be performed in clinical facilities approved for eye surgery by the Care Quality Commission.
When is the study starting and how long is it expected to run for?
January 2013 to January 2017
Who is funding the study?
See Again Europe Ltd (UK)
Who is the main contact?
CEO, Steve Jennings
steve@seeagain.co.uk
Contact information
Scientific
The Prospect Eye Clinic
Market Street
Altrincham
WA14 1PF
United Kingdom
| deryn@brendanmoriarty.com |
Study information
| Study design | Proof of concept trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Double intra-ocular lens implant for visual rehabilitation of patients with dry age-related macular degeneration |
| Study acronym | MDSAT1 |
| Study objectives | The study will evaluate the performance of the See Again Lens device, using an established surgical procedure, to improve vision in patients with macular disease. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Age-related macular degeneration |
| Intervention | Patient suitability: An ocular examination to determine patients suitability for the See Again assessment, usually 30 minutes duration. Confirmation from patients GP that there is no reason why the patient should not be part of the trial. Patient assessment: An ocular assessment using the See Again lens set that predicts the visual acuity improvement of the implant procedure, usually 15 minutes duration. Independent assessment: An independent ocular assessment of the patient before the implant procedure is performed, usually 1 hour duration. Pre operation assessment: An ocular examination performed immediately prior to performing the implant procedure, expected to take 15 minutes. Implant the lens system: Perform the implant procedure of the See Again lens system under local anesthetic, expected to take 45 minutes. Post operation assessment: Initial ocular examination within 24 hrs of the implant procedure being performed, expected to take 15 minutes. 2 weeks post operation assessment: Ocular examination 2 weeks post performing the implant procedure, expected to take 30 minutes. 4 weeks post operation assessment: Ocular examination 4 weeks post performing the implant procedure, expected to take 30 minutes. 8 weeks post operation assessment: Ocular examination 8 weeks post performing the implant procedure, expected to take 30 minutes. 12 weeks post operation assessment: Ocular examination 12 weeks post performing the implant to determine that vision has stabilised, expected to take 30 minutes. Independent post operation assessment: Independent visual acuity test to be performed after 3 months, usually 1 hour duration. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. An improvement from baseline in the patients final best corrected visual acuity (using ETDRS Chart). An improvement of 2 lines or more will constitute a positive result for a patient. 2. Mean or median improvement values will also be analysed at 3 months. The measures of the independent assessor will be employed. |
| Secondary outcome measures | The proof of concept secondary outcome measures are 1. Endothelial cell count will be compared to the patients baseline. A deterioration of less than 20% will constitute a positive result. 2. Improved mobility of the patient, this will be subjective based on patient response. Any perceived improvement in mobility will constitute a positive result. 3. Improved wellbeing of the patient, this will be subjective based on patient response to navigational capability and dependence on relatives and/or carers. Any perceived improvement in wellbeing will constitute a positive result. If successful, much larger trials will be undertaken in Ireland, UK and France that will define the predictability and reproducibility of performing the implant procedure.The health economics case will be collected from the same group of patients over a longer period (2 years) and will be based based on changes to direct healthcare costs, indirect healthcare costs and care costs in the community. |
| Overall study start date | 01/01/2013 |
| Completion date | 01/01/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | The proof of concept trial will have 7 patients. Based on these results Prof Leslie Daly, UCD, will define the number of participants for trials in Ireland, France and UK. |
| Key inclusion criteria | 1. The ophthalmic surgeon will select suitable patients 2. Patients with significant stable macular degeneration (dry), ideally with less than two disc diameters of ARMD 3. Patients must have significant lens opacities in the affected eye and a visual acuity of <6/36 4. Patients must have an endothelial cell count greater than 1,600 per square mm in the affected eye 5. Patients must demonstrate a positive screening test result when using the the See Again assessment lens set i.e. exhibit at least a two line improvement when reading the ETDRS Chart |
| Key exclusion criteria | 1. Patients with active ARMD 2. Patients with active ocular inflammation 3. Patients with previous cataract surgery 4. Patients with lack of mental capability to give informed consent 5. Patients with an inability to understand spoken and written English 6. Patients who are involved or have been involved in a research study |
| Date of first enrolment | 01/01/2013 |
| Date of final enrolment | 01/01/2017 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
WA14 1PF
United Kingdom
Sponsor information
Industry
c/o Stephen Jennings
Fence House
Fence Avenue
Macclesfield
SK10 2SX
United Kingdom
| steve@seeagain.co.uk | |
| Website | http://www.seeagain.co.uk |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
06/04/2016: Plain English summary added.
