Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 12:36 AM
Study NCT ID:
NCT03900260
Status:
COMPLETED
Last Update Posted:
2024-02-15
First Post:
2019-04-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of the Lenstec Softec HP1 Intraocular Lens
Sponsor:
Lenstec Incorporated
Organization:
Study Overview
Official Title:
Clinical Evaluation of the Lenstec Softec HP1 Intraocular Lens
Status:
COMPLETED
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is designed as a post market evaluation of the Softec HP1 IOL for continuance of the CE certificate. The primary effectiveness endpoint is to evaluate the safety and performance levels produced by this IOL in patients requiring standard cataract surgery. There will be no change from standard procedure, other than 1 extra post op evaluation.
Detailed Description:
Recruitment will be performed by the 3 Clinical Investigators (Jean-Pierre Danjoux - Sunderland Eye Infirmary, Karen Goodall - Croft Shifa Health Center, Mark Benson - Midland Eye Institute) and any appropriate, pre-trained staff within the hospital using the inclusion and exclusion criteria set out in the protocol. Patient selection will involve anyone over the age of 21 with an age-related cataract regardless of ethnicity, religion or gender.
An Informed Consent Form (ICF) will be explained with patients in full which will be signed by both the Principal Investigator (PI) and the patient with full understanding. Understanding fully means that the patient understands the nature of the operation, the benefits to the operation and also any risks or burdens.
The consent form also states alternatives to participation in the trial other than the option being put forward. The patients will be of sound enough mind to retain the information from the ICF and will be given time to digest this in order to make a free and effective decision to join the study.
All risks and benefits are explained in the ICF and are no more or less than that of a standard cataract surgery provided on a daily basis by NHS consultants. All surgeries will be performed by the PI.
Confidentiality shall be kept at all times with the PI and clinical staff using a unique patient reference number that in no instance indicates the identity of the patient to the study sponsor (Lenstec Inc.) or anyone else outside of the hospital. Any other confidentiality issues will run in conjunction with the hospital policy of which the staff involved in the study are aware.
There are no tissue samples to be used in this study.
An Informed Consent Form (ICF) will be explained with patients in full which will be signed by both the Principal Investigator (PI) and the patient with full understanding. Understanding fully means that the patient understands the nature of the operation, the benefits to the operation and also any risks or burdens.
The consent form also states alternatives to participation in the trial other than the option being put forward. The patients will be of sound enough mind to retain the information from the ICF and will be given time to digest this in order to make a free and effective decision to join the study.
All risks and benefits are explained in the ICF and are no more or less than that of a standard cataract surgery provided on a daily basis by NHS consultants. All surgeries will be performed by the PI.
Confidentiality shall be kept at all times with the PI and clinical staff using a unique patient reference number that in no instance indicates the identity of the patient to the study sponsor (Lenstec Inc.) or anyone else outside of the hospital. Any other confidentiality issues will run in conjunction with the hospital policy of which the staff involved in the study are aware.
There are no tissue samples to be used in this study.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: