Improving vision in patients with end-stage age-related macular degeneration using a miniature telescope implant
A Prospective, Multicenter Post-marketing Clinical Investigation of the SING IMT(TM) System, Model NG SI IMT 3X in Patients With Central Vision Impairment Associated With End-stage Age-related Macular Degeneration
This study is testing a tiny telescope implant to see if it can help older adults with severe vision loss from age-related macular degeneration see better after cataract surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | VisionCare, Inc. Industry-sponsored |
| Locations | 13 sites (Brussels and 12 other locations) |
| Trial ID | NCT04796545 on ClinicalTrials.gov |
What this trial studies
This clinical investigation aims to evaluate the safety and effectiveness of the SING IMT 3X implant in patients suffering from central vision impairment due to end-stage Age-related Macular Degeneration (AMD). Eligible participants, aged 55 and older, will undergo outpatient surgery to implant the device during routine cataract surgery. Following the procedure, patients will be monitored for 12 months with regular ophthalmic evaluations and will participate in vision training sessions to maximize the benefits of the implant. The study will assess visual acuity improvements and track any surgical complications or adverse events.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 55 and older with central vision impairment from end-stage AMD who meet specific visual acuity criteria.
Not a fit: Patients with better than 20/80 visual acuity or those who do not show potential improvement with the external telescope simulator may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the quality of life for patients with severe vision impairment due to AMD.
How similar studies have performed: Previous studies involving similar implantable devices have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria:
1. Be 55 years of age or older.
2. Have retinal findings of geographic atrophy or disciform scar with foveal involvement as determined by fluorescein angiography or OCT.
3. Have evidence of cataract.
4. Have best-corrected distance visual acuity (BCDVA) no better than 20/80 (0.6 LogMAR) and no worse than 20/800 (1.6 LogMAR) in both eyes.
5. Have adequate peripheral vision in the eye not scheduled for surgery, assessed by observation of ambulation.
6. Achieve at least a five-letter improvement on the ETDRS chart in the eye scheduled for surgery when using Samsara's 2.8X external telescope simulator (ETS, supplied separately).
7. Have an ACD of at least 2.5 mm in the eye scheduled for surgery.
8. Be willing to participate in a post-operative training program for the use of the NG SI IMT 3X implant.
9. Review and sign the Independent Ethics Committee (IEC)-approved Informed Consent Form (ICF) prior to any study-related procedures being performed.
10. Have adequate understanding of the local language to understand verbal and written subject information and be willing to comply with the study requirements.
Exclusion Criteria:
1. Evidence of active choroidal neovascularization (CNV) on fluorescein angiography or OCT or were treated for CNV within the past six months.
2. Any ophthalmic pathology that compromises the patient's peripheral vision in the fellow eye.
3. A history of steroid-responsive rise in IOP, uncontrolled glaucoma, or preoperative IOP\>22 mm Hg.
4. Corneal guttata.
5. Known sensitivity to post-operative medications.
6. Significant communication impairment or severe neurological disorders.
7. Have undergone previous intraocular or corneal surgery of any kind in the operative eye, including any type of surgery for either refractive or therapeutic purposes.
8. An ocular condition that predisposes the patient to eye rubbing.
9. Prior or expected ophthalmic-related surgery within 30 days preceding the NG SI IMT 3X implant surgery.
10. Patients for whom the planned operative eye has:
* Myopia \> 6.0 D
* Hyperopia \> 4.0 D
* Axial length \< 21 mm
* Endothelial cell density \< 1600 cells per square mm
* Narrow angle, i.e., \< Schaffer grade 2.
11. Inflammatory ocular disease.
12. Cornea stromal or endothelial dystrophies, including guttata.
13. Zonular weakness/instability of crystalline lens, or pseudoexfoliation.
14. Diabetic retinopathy.
15. Untreated retinal tears.
16. Retinal vascular disease.
17. Optic nerve disease.
18. A history of retinal detachment.
19. Retinitis pigmentosa.
20. Intraocular tumor.
21. Have received any investigational product within 30 days prior to study enrollment or be planning to participate in another investigation during the course of this study.
22. Be an employee (or a relative of an employee) of the contract research organization (CRO) responsible for conducting the study, Sponsor, or Sponsor representative.
23. Have a condition or be in a situation that, in the Investigator's opinion, may put the Subject at significant risk, may confound the study results, or may interfere significantly with the Subject's participation in the study.
Where this trial is running
Brussels and 12 other locations
- UZ Brussel — Brussels, Belgium (Recruiting)
- Centre d'Ophtalmologie Paradis-Monticelli — Marseille, France (Recruiting)
- Hélios Ophtalmologie, Saint-Jean-de-Luz — Saint-Jean-de-Luz, France (Recruiting)
- CHRU de Strasbourg — Strasbourg, France (Recruiting)
- Augenklinik Städtisches Klinikum Karlsruhe — Karlsruhe, Germany (Terminated)
- Universitätsklinikum Münster Klinik für Augenheilkunde — Münster, Germany (Recruiting)
- Mater Misericordiae University Hospital — Dublin, Ireland (Recruiting)
- Università degli Studi di Napoli Federico II — Naples, Italy (Recruiting)
- Fondazione Policlinico Universitario Agostino Gemelli — Roma, Italy (Recruiting)
- Vissum — Alicante, Spain (Recruiting)
- Institut OMIQ — Barcelona, Spain (Recruiting)
- Hospital Universitario La Luz - Quirónsalud — Madrid, Spain (Recruiting)
- Royal Victoria Hospital Belfast Health & Social Care Trust — Belfast, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Anne Roller, PhD
- Email: clinicals@medevise-consulting.com
- Phone: + 33 (0)3 88 30 88 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.