Implantation of a new intraocular lens for patients who require a new lens

ISRCTN	ISRCTN10015880
DOI	https://doi.org/10.1186/ISRCTN10015880

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Dr Edoardo Abed
Scientific

Via Carlo Forlanini, 34
Forlì
47121
Italy

Phone	+39 (0)543 731111
Email	edoardo.abed@auslromagna.it

Study information

Study design	Interventional non-masked study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	No participant information sheet available
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	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
Secondary outcome measures	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
Overall study start date	01/06/2017
Completion date	30/11/2020

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Both
Target number of participants	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

Morgagni Pierantoni Hospital

Department of Ophthalmology
Via Carlo Forlanini, 34
Forlì
47121
Italy

San Marino State Hospital

Department of Ophthalmology
Via Vittorio Scialoja, 40
Republic of San Marino
47893
San Marino

Sponsor information

Ospedale G.B. Morgagni - L.Pierantoni
Hospital/treatment centre

Via Carlo Forlanini,34
Forlì
47121
Italy

Phone	+39 3337785116
Email	giacomo.costa@auslromagna.it
Website	http://www.ausl.fo.it/AziendaUSLdellaRomagnaForl%C3%AC/Ospedali/Unit%C3%A0Operative/tabid/211/Default.aspx
"ROR"	https://ror.org/03jd4q354

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	30/10/2021
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Stored in repository
Publication and dissemination plan	Planned publication in a impacted peer-reviewed journal.
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

Editorial Notes

12/04/2022: Publication reference added.
29/06/2021: Trial's existence confirmed by Ospedale G.B. Morgagni - L.Pierantoni.