Clinical Evaluation of the Lenstec Softec HP1 Intraocular Lens

Aphakia Clinical Trial

Official title:

Clinical Evaluation of the Lenstec Softec HP1 Intraocular Lens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03900260
• Other study ID #: PR505
• Status: Completed
• Phase: N/A
• Start date: April 25, 2019
• Est. completion date: July 22, 2021

Study information

• Verified date: February 2024
• Source: Lenstec Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. There will be no change from standard procedure, other than 1 extra post op evaluation.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: July 22, 2021
• Est. primary completion date: July 22, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aphakia

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Croft Shifa health Centre	Rochdale
United Kingdom	Midland Eye Institute	Solihull
United Kingdom	Sunderland Eye Infirmary	Sunderland

Sponsors (1)

Lead Sponsor	Collaborator
Lenstec Incorporated

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complication Rates	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.	3 months
Primary	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.	3 months
Secondary	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.	3 months