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Clinical Evaluation of the Lenstec Softec HP1 Intraocular Lens

Sponsor
Lenstec Incorporated (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03900260
Collaborator
(none)
75
Enrollment
3
Locations
1
Arm
14.2
Anticipated Duration (Months)
25
Patients Per Site
1.8
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Softec HP1 Intraocular Lens
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Clinical Evaluation of the Lenstec Softec HP1 Intraocular Lens
Actual Study Start Date :
Apr 25, 2019
Anticipated Primary Completion Date :
Jun 1, 2020
Anticipated Study Completion Date :
Jun 29, 2020

Arms and Interventions

Arm Intervention/Treatment
Other: 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.

Outcome Measures

Primary Outcome Measures

  1. Best Corrected Distance Visual Acuity (BCDVA) [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) [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Croft Shifa health Centre Rochdale United Kingdom OL16 2UP
2 Midland Eye Institute Solihull United Kingdom B91 2AW
3 Sunderland Eye Infirmary Sunderland United Kingdom SR2 9HP

Sponsors and Collaborators

  • Lenstec Incorporated

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lenstec Incorporated
ClinicalTrials.gov Identifier:
NCT03900260
Other Study ID Numbers:
  • PR505
First Posted:
Apr 3, 2019
Last Update Posted:
Feb 26, 2020
Last Verified:
Apr 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Aphakia

Study Results

No Results Posted as of Feb 26, 2020