Implantation of a new intraocular lens for patients who require a new lens
| ISRCTN | ISRCTN10015880 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10015880 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Ospedale G.B. Morgagni - L.Pierantoni |
| Funder | Investigator initiated and funded |
- Submission date
- 23/06/2021
- Registration date
- 29/06/2021
- Last edited
- 12/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Due to trauma or surgery, the natural or artificial intraocular lens may dislocate causing vision loss. The aim of the study is to determine the efficacy of the implant of a new intraocular lens to restore vision in these patients.
Who can participate?
Patients affected by aphakia or IOL dislocation
What does the study involve?
This study involves surgery to remove the luxated lens from the eye and implant an artificial intraocular lens to restore vision.
What are the possible benefits and risks of participating?
Possible benefits are an increase in vision and the reduction of the risk of further visual loss. The possible risks are the development of surgical complications possibly leading to further vision loss or to the need for further surgery.
Where is the study run from?
Morgagni Pierantoni Hospital (Italy)
When is the study starting and how long is it expected to run for?
June 2017 to November 2020
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Edoardo Abed
edoardoabed@yahoo.it
Contact information
Scientific
Via Carlo Forlanini, 34
Forlì
47121
Italy
| Phone | +39 (0)543 731111 |
|---|---|
| edoardo.abed@auslromagna.it |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional non-masked study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | One year outcomes and stability of a novel scleral anchored intraocular lens |
| Study acronym | NSAIL |
| Study objectives | To assess 1-year outcomes and stability of a novel scleral anchored intraocular lens. |
| Ethics approval(s) | The study does not require ethics approval since the treatment protocol is already approved. Furthermore, no patient identifiable data were reported in the study. |
| Health condition(s) or problem(s) studied | Aphakia |
| Intervention | The study is a single arm trial. All patients underwent surgery consisting of vitrectomy, removal of dislocated lens and implantation of scleral fixation intraocular lens at baseline. Postoperative follow-up extended until 12 months after surgery. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) | Visual acuity was measured in decimal Snellen units and then converted in Logarithm of minimum angle resolution (LogMAR) for statistical purposes assessed at baseline and at 1,3,6 and 12 months follow up |
| Key secondary outcome measure(s) | Assessed at baseline and at 1,3,6 and 12 months follow up 1. IOL stability was assessed comparing the angle, in degrees, between IOL optic and posterior iris plane. 2. Complications assessed using patient records |
| Completion date | 30/11/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 60 |
| Key inclusion criteria | Postoperative or posttraumatic aphakia or late dislocation of IOL and or capsular bag |
| Key exclusion criteria | 1. Corneal opacities 2. Visually significant macular diseases 3. Retinal detachment 4. Optic disk atrophy 5. Advanced glaucoma 6. Any other ocular condition that was likely to compromise the functional outcome |
| Date of first enrolment | 01/11/2017 |
| Date of final enrolment | 30/11/2019 |
Locations
Countries of recruitment
- Italy
- San Marino
Study participating centres
Via Carlo Forlanini, 34
Forlì
47121
Italy
Via Vittorio Scialoja, 40
Republic of San Marino
47893
San Marino
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in repository |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 26/08/2021 | 12/04/2022 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
12/04/2022: Publication reference added.
29/06/2021: Trial's existence confirmed by Ospedale G.B. Morgagni - L.Pierantoni.
