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Clinical Evaluation of the Lenstec Softec HP1 Intraocular Lens

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ClinicalTrials.gov Identifier: NCT03900260
Recruitment Status : Not yet recruiting
First Posted : April 3, 2019
Last Update Posted : April 4, 2019
Sponsor:
Information provided by (Responsible Party):
Lenstec Incorporated

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.

Condition or disease Intervention/treatment Phase
Aphakia Device: Softec HP1 Intraocular Lens Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical Evaluation of the Lenstec Softec HP1 Intraocular Lens
Estimated Study Start Date : April 11, 2019
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Uncorrected Distance Visual Acuity (UCDVA) [ Time Frame: 3 months ]
    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.


Other Outcome Measures:
  1. Complication Rates [ Time Frame: 3 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. ≥ 21 years of age, of any race and either gender
  2. Operable, age related cataract grade in one or both eyes
  3. Patients who require an IOL power in the range of 10.0 - 30.0 D only
  4. Able to comprehend and sign a statement of informed consent
  5. Planned cataract removal by phacoemulsification
  6. Potential postoperative visual acuity of 0.2 logMAR or better
  7. No other ocular or systemic pathology that may affect visual outcome following cataract surgery
  8. Clear intraocular media other than cataract in study eyes
  9. Preoperative Best Corrected Visual Acuity (BCVA - VA taken with original manifest refraction) worse than 0.2 logMAR
  10. Able to competently complete testing
  11. Willing and able to attend study visits

Exclusion Criteria:

  1. Previous intraocular surgery
  2. Previous corneal refractive surgery
  3. Any inflammation or oedema (swelling) of the cornea
  4. Pterygium with corneal involvement or has the potential of corneal involvement (in the opinion of the Investigator)
  5. Amblyopia
  6. Clinically significant ptosis
  7. Clinically severe corneal dystrophy (e.g. epithelial, stromal, or endothelial dystrophy), keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or kerectasia
  8. Diabetic Retinopathy
  9. Previous retinal detachment
  10. Previous corneal transplant
  11. Iris neovascularization
  12. Glaucoma (medically controlled or uncontrolled)
  13. Aniridia
  14. Chronic severe uveitis
  15. Optic nerve atrophy
  16. Corneal decompensation
  17. History of corneal disease (e.g. herpes simplex, herpes zoster keratitis, etc.)
  18. Pseudoexfoliation syndrome
  19. Iris atrophy
  20. Aniseikonia
  21. 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.
  22. Participation in another clinical trial within 30 days of study start

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03900260


Contacts
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Contact: Jessica Walcott 2464206795 jwalcott@lenstec.com
Contact: Ian Hickling 2464206795 ihickling@lenstec.com

Locations
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United Kingdom
Sunderland Eye Infirmary Not yet recruiting
Sunderland, United Kingdom, SR2 9HP
Contact: Jean-Pierre Danjoux, MD    07770921247    j.danjoux@icloud.com   
Sponsors and Collaborators
Lenstec Incorporated
Investigators
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Principal Investigator: Jean-Pierre Danjoux, MD Sunderland Eye Infirmary
Principal Investigator: Karen Goodall, MD Croft Shifa Health Center
Principal Investigator: Mark Benson, MD Midland Eye Institute

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Responsible Party: Lenstec Incorporated
ClinicalTrials.gov Identifier: NCT03900260     History of Changes
Other Study ID Numbers: PR505
First Posted: April 3, 2019    Key Record Dates
Last Update Posted: April 4, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Aphakia
Lens Diseases
Eye Diseases