Rotational Stability and Clinical Response of the ASQELIO Toric Biaspheric Monofocal Lens.

NCT06101472 | Unknown

• 1 other identifier: ASQM022023
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 3

Brief Summary

The goal of this observational study is to evaluate the rotational stability and clinical performance of the ASQELIO Toric lens in candidates for cataract surgery with ASQUELIO Toric intraocular lens (IOL) implantation. Information will be obtained from patients operated by routine clinical practice with toric monofocal ASQELIO IOL in at least one eye. After confirmation of inclusion, the preoperative examination will be performed, and after surgery an evaluation will be performed the following day, one week, one month and three months after surgery.

Conditions

Cataract

Keywords

Cataract

Outcome Measures

Primary Outcomes (2)

• Rotational stability of the implant

  Evaluated at each visit by analysis of slit-lamp backlight images, following the method described by Wolffsohn and Buckhurst. By means of backlighting, the IOL markings indicating the axis in which the astigmatic power is located will be observed and by image analysis it will be determined and quantified whether the lens has been rotated.

  During 3 months after IOL implantation

• Visual acuity

  Best corrected distance visual acuity in LogMAR units using the ETDRS chart

  During 3 months after IOL implantation

Secondary Outcomes (3)

• Refraction

  During 3 months after IOL implantation

• Adverse events

  During 3 months after IOL implantation

• Satisfaction and quality of vision questionnaire

  During 3 months after IOL implantation

Study Arms (1)

Pseudophakic subjects implanted with the ASQELIO toric IOL

Adult subjects undergoing cataract surgery by routine clinical practice with ASQELIO Toric Biaspheric Monofocal Lens in at least one eye.

Device: ASQELIO Toric Biaspheric Monofocal Lens

Interventions

ASQELIO Toric Biaspheric Monofocal Lens DEVICE

Intraocular lens implantation in cataract surgery

Pseudophakic subjects implanted with the ASQELIO toric IOL

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subjects who are candidates for cataract surgery and implantation of toric monofocal ASQELIO IOL in at least one of their eyes.

You may qualify if:

• Subjects 22 years of age or older undergoing cataract surgery in at least 1 eye and implanted with LIO ASQELIO.
• Subjects for whom postoperative emmetropia was planned (±0.5 D spherical equivalent)

You may not qualify if:

• Preoperative corneal astigmatism less than 0.75D
• Patients who do not provide informed consent
• Patients who do not understand the study procedure.
• Previous corneal surgery or trauma.
• Irregular cornea (e.g. keratoconus).
• Microphthalmos.
• Severe corneal dystrophy.
• Pregnant or breastfeeding'.
• Rubella
• Mature/dense cataract making eye bottom preoperative examination difficult.
• Previous retinal detachment.
• Concurrent participation in other research with drugs or clinical devices.
• Expect to require another eye surgery during the study period.

Sponsors & Collaborators

• AST Products, Inc.: lead

Study Sites (3)

Oftalvist Alicante

Alicante, 03013, Spain

RECRUITING

OftalVist Madrid

Madrid, 28006, Spain

RECRUITING

OftalVist Valencia

Valencia, 46004, Spain

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Pedro Tañá, Dr

  Oftalmología Vistahermosa SL

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Cobo, Dr

CONTACT

+34963513304; maria.cobo@oftalvist.es

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2023
• First Posted: October 26, 2023
• Study Start: February 1, 2024
• Primary Completion: August 1, 2024
• Study Completion: October 1, 2024
• Last Updated: January 31, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)