Clinical Evaluation of the Lenstec Softec HP1 Intraocular Lens

Last updated: February 13, 2024
Sponsor: Lenstec Incorporated
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

Softec HP1 Intraocular Lens

Clinical Study ID

NCT03900260
PR505
  • Ages > 21
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 followingcataract surgery
  8. Clear intraocular media other than cataract in study eyes
  9. Preoperative Best Corrected Visual Acuity (BCVA - VA taken with original manifestrefraction) worse than 0.2 logMAR
  10. Able to competently complete testing
  11. Willing and able to attend study visits

Exclusion

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 theopinion of the Investigator)
  5. Amblyopia
  6. Clinically significant ptosis
  7. Clinically severe corneal dystrophy (e.g. epithelial, stromal, or endothelialdystrophy), 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 trialNote: Patients who become pregnant during the study will not be discontinued; however,data may be excluded from the effectiveness analyses because pregnancy can alterrefraction and visual acuity results.
  22. Participation in another clinical trial within 30 days of study start

Study Design

Total Participants: 87
Treatment Group(s): 1
Primary Treatment: Softec HP1 Intraocular Lens
Phase:
Study Start date:
April 25, 2019
Estimated Completion Date:
July 22, 2021

Study 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.

Connect with a study center

  • Croft Shifa health Centre

    Rochdale, OL16 2UP
    United Kingdom

    Site Not Available

  • Midland Eye Institute

    Solihull, B91 2AW
    United Kingdom

    Site Not Available

  • Sunderland Eye Infirmary

    Sunderland, SR2 9HP
    United Kingdom

    Site Not Available

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