AphakiaNCT03900260
Clinical Evaluation of the Lenstec Softec HP1 Intraocular Lens
A study testing Softec HP1 Intraocular Lens in people with Aphakia, run by Lenstec Incorporated at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aphakia
- What is being tested?
- Softec HP1 Intraocular Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 25 Apr 2019to 22 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥ 21 years of age, of any race and either gender
- Operable, age related cataract grade in one or both eyes
- Patients who require an IOL power in the range of 10.0 - 30.0 D only
- Able to comprehend and sign a statement of informed consent
- Planned cataract removal by phacoemulsification
- Potential postoperative visual acuity of 0.2 logMAR or better
Show all 11Show fewer
- No other ocular or systemic pathology that may affect visual outcome following cataract surgery
- Clear intraocular media other than cataract in study eyes
- Preoperative Best Corrected Visual Acuity (BCVA - VA taken with original manifest refraction) worse than 0.2 logMAR
- Able to competently complete testing
- Willing and able to attend study visits
Who cannot join
- Previous intraocular surgery
- Previous corneal refractive surgery
- Any inflammation or oedema (swelling) of the cornea
- Pterygium with corneal involvement or has the potential of corneal involvement (in the opinion of the Investigator)
- Amblyopia
- Clinically significant ptosis
Show all 22Show fewer
- Clinically severe corneal dystrophy (e.g. epithelial, stromal, or endothelial dystrophy), keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or kerectasia
- Diabetic Retinopathy
- Previous retinal detachment
- Previous corneal transplant
- Iris neovascularization
- Glaucoma (medically controlled or uncontrolled)
- Aniridia
- Chronic severe uveitis
- Optic nerve atrophy
- Corneal decompensation
- History of corneal disease (e.g. herpes simplex, herpes zoster keratitis, etc.)
- Pseudoexfoliation syndrome
- Iris atrophy
- Aniseikonia
- Pregnant, lactating, or planning to become pregnant during the course of the trial Note: Patients who become pregnant during the study will not be discontinued; however, data may be excluded from the effectiveness analyses because pregnancy can alter refraction and visual acuity results.
- Participation in another clinical trial within 30 days of study start
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Croft Shifa health Centre
Rochdale, OL16 2UP
Midland Eye Institute
Solihull, B91 2AW
Sunderland Eye Infirmary
Sunderland, SR2 9HP
About this study
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.
Read the 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.
- Conditions
- Aphakia
- Being tested
- Softec HP1 Intraocular Lens
- Medical subject headings
- Aphakia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Softec HP1 Intraocular LensDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Softec HP1 Intraocular Lens | Other | 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. Receives: Device: Softec HP1 Intraocular Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start25 Apr 2019
- Primary completion22 Jul 2021
- Study completion22 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphakiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lenstec Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Pierre Danjoux, MD, Principal investigator, Sunderland Eye InfirmaryKaren Goodall, MD, Principal investigator, Croft Shifa Health CenterMark Benson, MD, Principal investigator, Midland Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03900260
- Sponsor's protocol ID
- PR505
- Status last verified
- Feb 2024
- First submitted
- 1 Apr 2019
- Last updated
- 15 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of the Lenstec Softec HP1 Intraocular Lens
- ClinicalTrials.gov ID
- NCT03900260
- Acronym / sponsor ID
- PR505
- Conditions
- Aphakia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Lenstec IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 22 Jul 2021 (actual)
- Study completion
- 22 Jul 2021 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Softec HP1 Intraocular Lens | Other | Device: Softec HP1 Intraocular LensThe 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ≥ 21 years of age, of any race and either gender
- Operable, age related cataract grade in one or both eyes
- Patients who require an IOL power in the range of 10.0 - 30.0 D only
- Able to comprehend and sign a statement of informed consent
- Planned cataract removal by phacoemulsification
Key exclusion criteria (22 listed)
- Previous intraocular surgery
- Previous corneal refractive surgery
- Any inflammation or oedema (swelling) of the cornea
- Pterygium with corneal involvement or has the potential of corneal involvement (in the opinion of the Investigator)
- Amblyopia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Softec HP1 Intraocular LensThe 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 |
Primary outcome
Best Corrected Distance Visual Acuity (BCDVA)
Time frame: 3 months
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.
1 secondary outcome
Uncorrected Distance Visual Acuity (UCDVA)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for Aphakia
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism
Recruiting
Clinical Evaluation of a Novel Trifocal IOL
Aphakia, Cataract
Active, not recruiting
Contralateral Claims Study of Clareon Vivity Pro
Aphakia, Presbyopia
Recruiting
Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL
Aphakia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Pierre Danjoux, MD principal investigator
Sunderland Eye Infirmary
Karen Goodall, MD principal investigator
Croft Shifa Health Center
Mark Benson, MD principal investigator
Midland Eye Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Softec HP1 Intraocular Lens in people with Aphakia, run by Lenstec Incorporated at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Distance Visual Acuity (BCDVA) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2024.