Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Mr Brendan Moriarty
ORCID ID
Contact details
The Prospect Eye Clinic
Market Street
Altrincham
WA14 1PF
United Kingdom
-
deryn@brendanmoriarty.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
See Again 100 001
Study information
Scientific title
Double intra-ocular lens implant for visual rehabilitation of patients with dry age-related macular degeneration
Acronym
MDSAT1
Study hypothesis
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
Not provided at time of registration
Study design
Proof of concept trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
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 trial start date
01/01/2013
Overall trial end date
01/01/2017
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
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.
Participant 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
Recruitment start date
01/01/2013
Recruitment end date
01/01/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Prospect Eye Clinic
Altrincham
WA14 1PF
United Kingdom
Sponsor information
Organisation
See Again Europe Ltd (UK)
Sponsor details
c/o Stephen Jennings
Fence House
Fence Avenue
Macclesfield
SK10 2SX
United Kingdom
-
steve@seeagain.co.uk
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
See Again Europe Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary