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OpenTrials
Completed

NCT Number: NCT06528678

Patients Outcomes of a Monofocal Intraocular Lens Designed for Monovision

The rationale for this observational study of a CE-marked lens is to prospectively assess the performance, safety, and patient satisfaction in a group of subjects undergoing cataract surgery with bilateral implantation of the RayOne EMV in a monovision configuration. In order to increase the evidence collected from real-world clinical data we are running a multicentre clinical study in several clinics of the Baviera Ophthalmological Group.

Study design: prospective, observational, non-comparative.

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Key information

Conditions

Cataract Behavior Eye Diseases Health Behavior Lens Diseases Patient Satisfaction Treatment Adherence and Compliance

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Baviera

Valencia, 46004, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent
  • Availability to complete follow-up examinations up to 6 months after surgery
  • Cataract for which removal by phacoemulsification and subsequent IOL implantation was planned
  • CDVA was expected to be better than 20/30 (+0.18 logMAR) after IOL implantation
  • IOL power calculated in the range of +10.0 to +30.0 D
  • Corneal astigmatism < 1.50 D
  • Candidate for refractive surgery in monovision configuration

Exclusion criteria

  • Women who were pregnant, nursing or planning to become pregnant during the study
  • Difficulty for cooperation
  • Inability to provide informed consent
  • Concurrent participation in another investigational drug or device
  • History of ocular trauma
  • Previous intraocular or corneal surgery
  • Presence of ocular pathologies
  • Subjects with diagnosed degenerative visual disorders that were predicted to cause future acuity losses to a level of 20/30 or worse
  • Subjects who may be expected to require retinal laser treatment
  • Other eye condition that in the opinion of the investigator prevents the subject's participation in the study.
  • Any other condition that may be contraindicated according to the IOL Instructions for Use.

Treatment and study plan

Intraocular lens

Device

Lens exchange with an intraocular lens

Primary outcomes

  1. Visual acuity

    Time frame: One month postoperative

    Visual acuity was measured using standard clinical charts

  2. Defocus curve

    Time frame: One month postoperative

    Defocus curve was measured using standard clinical charts

  3. Patient Satisfaction

    Time frame: One month postoperative

    Patient satisfaction was measured using the Cataract Assessment Patient Questionnaire 9 Short Form (Catquest 9SF) from 1 to 5, being 1 major difficulties and 5 cannot decide

Secondary outcomes

  1. Safety of the device

    Time frame: Surgery, first follow-up visit (1-month) and second follow-up visit (6-months)

    Safety of the device was measured in terms of the frequency of adverse events related to the device

  2. Quality of vision

    Time frame: One month postoperative

    Quality of vision was measured using a self-administered questionnaire developed at Clinica Baviera to assess patient satisfaction regarding night vision, from 1 to 4 being 1 the maximun score and 4 the worst score

Sponsors and collaborators

Lead sponsor

Clinica Baviera

Other

Registry information

Official study title

Visual Outcomes and Patient Satisfaction Results After Implantation of a Monofocal Intraocular Lens Designed for Monovision

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 30, 2024
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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