An interventional study of Softec HP1 Intraocular Lens in Aphakia, sponsored by Lenstec Incorporated. Completed at 3 sites in United Kingdom. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-15.
Sponsored by Lenstec Incorporated · Not applicable, Interventional, and Other
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.
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.
69 studies on the registry are indexed under Aphakia; 6 are open to participants now.
This study's enrollment of 87 is below the median of 103 across 52 interventional studies indexed under Aphakia.
Browse Aphakia studies →Lenstec Incorporated is the lead sponsor of 6 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Softec HP1 IOL is a single-piece, biconvex, ultraviolet absorbing intraocular lens designed for insertion into the posterior chamber of the human eye for visual correction of Aphakia in adults over the age of 21, and as a replacement of a damaged (cataract) natural lens.
Device: Softec HP1 Intraocular Lens
The Softec HP1 IOL is a single-piece, biconvex, ultraviolet absorbing intraocular lens designed for insertion into the posterior chamber of the human eye for visual correction of Aphakia in adults over the age of 21, and as a replacement of a damaged (cataract) natural lens.
Best Corrected Distance Visual Acuity (BCDVA)
The postoperative BCDVA for up to 75 patients will be measured under normal lighting conditions using a phoropter or trial frames, and these results will be evaluated by the sponsor on completion of the study.
Time frame: 3 months
Uncorrected Distance Visual Acuity (UCDVA)
The postoperative UCDVA for up to 75 patients will be measured under normal lighting conditions using a phoropter or trial frames, and these results will be evaluated by the sponsor on completion of the study.
Time frame: 3 months
Complication Rates
Up to 75 patients will be evaluated for intraoperative and postoperative complications, and these will be compared to the complication rates provided in the FDA Grid.
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2019 to primary completion in Jul 2021, 26 months.
Of 32 industry-sponsored interventional studies with no phase under Aphakia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 23. This study's 26 months is above that.
Counting every sponsor, half of 37 studies reached it within 17 months; a quarter within 9 and three quarters within 26.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
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Lenstec Incorporated