Retrospective Clinical Investigation of the Safety and Performance of 640PM Trifocal IOL Implantation in Patients With Cataract and/or Ametropia (Hyperopia, Myopia) and/or Presbyopia

Cataract Clinical Trial

Official title:

Retrospective Clinical Investigation of the Safety and Performance of 640PM Trifocal IOL Implantation in Patients With Cataract and/or Ametropia (Hyperopia, Myopia) and/or Presbyopia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05735990
• Other study ID #: M_640PM_ES_2202
• Status: Completed
• Start date: October 27, 2022
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2023
• Source: Medicontur Medical Engineering Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The clinical investigation objective is to evaluate safety and performance outcomes of trifocal IOL implantation to improve vision in patients with cataract and/or ametropia (hyperopia, myopia) and/or presbyopia.

Retrospective data from preoperative status up to 12 month postoperative status will be collected from patients that were implanted with Medicontur's 640PM intraocular lens:

• Preoperative status: Preoperative Screening and Baseline

• Surgery: IOL implantation

• M1: 1 month +/- 2 weeks postoperative follow-up

• M3: 3 months +/- 1 month postoperative follow-up

• M12: 12 months +/- 3 months postoperative follow-up

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult males or females above 18 years of age;

• Pseudophakic patients implanted with 640PM IOLs (Medicontur Medical Engineering Ltd. Inc., Zsámbék, Hungary);

• Diagnosis of cataract and/or ametropia and/or presbyopia;

• Subject who provided express consent authorizing the use of medical record data for biomedical research purposes. Patients who have participated in at least two follow up visits in the 12 months following IOL implantation

• Patients for which the retrospective data for the primary endpoint is available and at least half of all the secondary endpoints measured in the time ranges specified in the protocol.

Exclusion Criteria:

• Patients with any eye condition that could affect vision (corneal ectasia, retinal diseases, glaucoma, uveitis, dry eye or amblyopia, etc.);

• regular anterior corneal astigmatism = 1.20 D or irregular astigmatism = 0.5 µm measured with Pentacam at 4 mm.

Related Conditions & MeSH terms

• Cataract
• Hyperopia
• Myopia
• Presbyopia
• Pseudophakia
• Refractive Errors

Intervention

Device:
• Intraocular lens
Aspheric hydrophilic acrylic IOL for implantation into the capsular bag

Locations

Country	Name	City	State
Spain	Hospital Vithas Almería	Almería

Sponsors (1)

Lead Sponsor	Collaborator
Medicontur Medical Engineering Ltd

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Secondary surgical intervention rate		12 months after IOL implantation;
Other	Collect and evaluate ocurrence of adverse events detected		from surgery to 12 months after IOL implantation
Other	PCO rate		12 months after IOL implantation
Other	Nd-YAG capsulotomy rate		12 months after IOL implantation
Primary	Corrected distance visual acuity (CDVA);		12 months after IOL implantation
Secondary	visual acuity at all intended distances (UDVA; CDVA, UIVA, DCIVA, UNVA, DCNVA)		1 and 12 months after IOL implantation;
Secondary	Manifest spherical equivalent refraction (SEQ)		3 and 12 months after IOL implantation
Secondary	VADC (monocular with best distance correction) under photopic conditions		3 months after IOL implantation
Secondary	CSDC (monocular with best distance correction): To evaluate CSDC under photopic conditions		3 months after IOL implantation;
Secondary	CSDC (binocular without best distance correction) under photopic and mesopic conditions		12 months after IOL implantation;
Secondary	Visual Function by VF-14		12 months after IOL implantation;
Secondary	Patient satisfaction self-reported by the participant		12 months after IOL implantation
Secondary	Visual disturbances (photic phenomena, dysphotopsia) self-reported by the participant		12 months after IOL implantation
Secondary	spectacle independence self-reported by the participant		12 months after IOL implantation