Implant two piece intra-ocular lens system for treating dry age-related macular degeneration
| ISRCTN | ISRCTN93069723 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93069723 |
| Protocol serial number | See Again 100 001 |
| Sponsor | See Again Europe Ltd (UK) |
| Funder | See Again Europe Ltd (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Proof of concept trial |
| Secondary study design | Non randomised study |
| Study type | Participant 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(s) |
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. |
| Key secondary outcome measure(s) |
The proof of concept secondary outcome measures are |
| Completion date | 01/01/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 7 |
| 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
- United Kingdom
- England
Study participating centre
WA14 1PF
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
06/04/2016: Plain English summary added.
