Clinical Evaluation of the Lenstec Softec HP1 Intraocular Lens
Primary Purpose
Aphakia
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Softec HP1 Intraocular Lens
Sponsored by
About this trial
This is an interventional other trial for Aphakia
Eligibility Criteria
Inclusion Criteria:
- ≥ 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
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Croft Shifa health CentreRecruiting
- Midland Eye Institute
- Sunderland Eye Infirmary
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Softec HP1 Intraocular Lens
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03900260
Brief Title
Clinical Evaluation of the Lenstec Softec HP1 Intraocular Lens
Official Title
Clinical Evaluation of the Lenstec Softec HP1 Intraocular Lens
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 25, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
June 29, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lenstec Incorporated
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aphakia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Softec HP1 Intraocular Lens
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Softec HP1 Intraocular Lens
Intervention Description
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.
Primary Outcome Measure Information:
Title
Best Corrected Distance Visual Acuity (BCDVA)
Description
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
Secondary Outcome Measure Information:
Title
Uncorrected Distance Visual Acuity (UCDVA)
Description
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
Other Pre-specified Outcome Measures:
Title
Complication Rates
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
≥ 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
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
Exclusion Criteria:
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
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Walcott
Phone
2464206795
Email
jwalcott@lenstec.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ian Hickling
Phone
2464206795
Email
ihickling@lenstec.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Danjoux, MD
Organizational Affiliation
Sunderland Eye Infirmary
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karen Goodall, MD
Organizational Affiliation
Croft Shifa Health Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Benson, MD
Organizational Affiliation
Midland Eye Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Croft Shifa health Centre
City
Rochdale
ZIP/Postal Code
OL16 2UP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Goodall, MD
Phone
01706655121
Email
karengoodall.pa@hotmail.com
Facility Name
Midland Eye Institute
City
Solihull
ZIP/Postal Code
B91 2AW
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Benson, MD
Phone
01217 112 020
Email
marktbenson@mac.com
Facility Name
Sunderland Eye Infirmary
City
Sunderland
ZIP/Postal Code
SR2 9HP
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Danjoux, MD
Phone
07770921247
Email
j.danjoux@icloud.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of the Lenstec Softec HP1 Intraocular Lens
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