Multicentric Clinical Study on Isatis TF Trifocal Intraocular Lens

NCT04465344 | Completed

• 1 other identifier: CE2001
• Study Type: interventional
• Target: 188
• Locations: 2 countries
• Sites: 7

Brief Summary

The study will be a multicentric, prospective open-label ethics committee approved clinical study to investigate safety, visual outcomes, contrast sensitivity and rotational stability after bilateral implantation of Isatis TF IOL following cataract surgery.

Conditions

Cataract; Lens Opacities

Keywords

Intraocular Lens; IOL; hydrophobic; trifocal

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint: Rates of Adverse Events

  The objective is to compare the SPE (Safety and Performance Endpoints) rates of the investigational product to reference data stated in the according ISO standard for posterior intraocular lenses (EN ISO 11979-7:2018) based on minimum 100 subjects.

  120-180 days postoperative

• Primary Performance Endpoint: Best Corrected Distance Visual Acuity

  The primary performance endpoint is to show non inferiority of Isatis TF compared to the monofocal comparator in terms of best corrected distance visual acuity (CDVA) by means of statistical significance.

  120-180 days postoperative

Secondary Outcomes (3)

• Secondary Safety Endpoint: Best Corrected Distance Visual Acuity compared to historical data

  120-180 days postoperative

• Secondary Performance Endpoint: Distance Corrected Near Visual Acuity (DCNVA)

  120-180 days postoperative

• Secondary Performance Endpoint: Distance Corrected Intermediate Visual Acuity (DCIVA)

  120-180 days postoperative

Other Outcomes (47)

• Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions

  Preoperative, 1-2 days postoperative; 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative

• Binocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions

  120-180 days postoperative, 330-420 days postoperative

• Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions

  Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative

Study Arms (2)

IOL implantation experimental

EXPERIMENTAL

Experimental arm: Trifocal intraocular lens Isatis TF

Device: Implantation of trifocal IOL, Isatis TF (device under investigation)

IOL implantation active comparator

ACTIVE COMPARATOR

Comparator arm: Monofocal intraocular lens Isatis

Device: Implantation of monofocal IOL, Isatis (control device)

Interventions

Implantation of trifocal IOL, Isatis TF (device under investigation) DEVICE

Patients will be implanted with study IOL in both eyes

IOL implantation experimental

Implantation of monofocal IOL, Isatis (control device) DEVICE

Patients will be implanted with Control IOL in both eyes

IOL implantation active comparator

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically documented age-related cataract in both eyes with no comorbidity;
• Calculated IOL power is within the range of the investigational IOLs;
• Male or female adults ages 50 years or older on the day of screening who have cataracts in both eyes;
• Regular corneal astigmatism (measured by topographer)
• Astigmatism ≤1.0 D (measured by an automatic keratometer)
• Clear intraocular media other than cataract;
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures;
• Signed informed consent.

You may not qualify if:

• Age of patient \< 50 years;
• Regular corneal astigmatism \>1.0 dioptres (measured by an automatic keratometer)
• Irregular astigmatism (measured by topographer);
• Difficulty for cooperation (distance from their home, general health conditions);
• Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders);
• Subjects with AMD suspicious eyes as determined by OCT examination;
• Previous intraocular or corneal surgery;
• Traumatic cataract;
• Instability of keratometry or biometry measurements; Acceptable maximum standard deviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D;
• Ocular hypertension, suspicious glaucoma or glaucoma;
• Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions);
• Expected complicated surgery;
• Ocular surface disease (clinical symptoms or keratitis);
• Pregnancy or lactation;
• Second eye treatment will only be performed when Best Corrected Distance Visual Acuity (CDVA) of first eye is ≤ 0.2 logMAR (≥ 0.63 decimal);

Sponsors & Collaborators

• Cutting Edge SAS: lead
• targomedGmbH: collaborator

Study Sites (7)

Gemini Eye Clinic Ostrava

Ostrava, 700 30, Czechia

Location

Gemini Eye Clinic Praha-Krc

Prague, 140 00, Czechia

Location

Gemini Eye Clinic Zlín

Zlín, 760 01, Czechia

Location

Hospital Donostia

Donostia / San Sebastian, 20014, Spain

Location

Oftalvist Madrid

Madrid, 28006, Spain

Location

Hospital Universitario Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Miguel Servet

Zaragoza, 50009, Spain

Location

Related Publications (3)

• McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26.

  PMID: 20505205 BACKGROUND

• Morlock R, Wirth RJ, Tally SR, Garufis C, Heichel CWD. Patient-Reported Spectacle Independence Questionnaire (PRSIQ): Development and Validation. Am J Ophthalmol. 2017 Jun;178:101-114. doi: 10.1016/j.ajo.2017.03.018. Epub 2017 Mar 22.

  PMID: 28341605 BACKGROUND

• Lundstrom M, Pesudovs K. Catquest-9SF patient outcomes questionnaire: nine-item short-form Rasch-scaled revision of the Catquest questionnaire. J Cataract Refract Surg. 2009 Mar;35(3):504-13. doi: 10.1016/j.jcrs.2008.11.038.

  PMID: 19251145 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 10, 2020
• Study Start: May 31, 2021
• Primary Completion: June 27, 2024
• Study Completion: June 27, 2024
• Last Updated: February 12, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (3); ES (4)