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Recruiting

NCT Number: NCT07481487

Outcomes of Cataract & Refractive Procedures

The primary objective of the database is to retrospectively analyse the visual and refractive outcomes of cataract and refractive procedures in order to continuously assess outcomes and also compare outcomes between the different IOLs, or the different refractive procedures.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vision Care Clinic Bristol

Bristol, England, BS8 1BN, United Kingdom

Location status: Recruiting

Location contact

Kieren Darcy, BM MRCS (Eng) CertLRS FRCOphth

CONTACT

[email protected]

+44 117 905 7722

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients who have undergone a refractive procedure
  • Adult patients who have undergone a cataract procedure with implantation of an intraocular lens
  • Age ≥ 18 years old
  • Patient able to consent for their pseudonymised data to be used for research purposes

Exclusion criteria

  • NONE

Treatment and study plan

Primary outcomes

  1. Post-operative Uncorrected Distance Visual Acuity

    Time frame: postoperative visit 3-6 months

  2. Post-operative Distance Corrected Visual Acuity

    Time frame: postoperative visit 3-6 months

  3. Post-operative subjective refraction (Sphere, Cylinder, Axis)

    Time frame: postoperative visit 3-6 months

  4. Accuracy of post-operative refraction achieved compared to targeted refraction

    Time frame: postoperative visit 3-6 months

  5. Loss of best-corrected visual acuity compared to preoperatively

    Time frame: postoperative visit 3-6 months

  6. Occurrence of surgical complications and post-operative complications

    Time frame: postoperative visit 3-6 months

  7. Post-operative Uncorrected Near Visual Acuity

    Time frame: postoperative visit 3-6 months

    For intraocular lens offering a visual benefit at near and/or intermediate, such as multifocal IOLs, EDoF (Extended Depth of Focus) IOLs, enhanced monofocal IOLs, and for refractive procedures offering a visual benefit at near and/or intermediate, additional visual outcomes and safety outcomes may be assessed.

  8. Post-operative Uncorrected Intermediate Visual Acuity

    Time frame: postoperative visit 3-6 months

    For intraocular lens offering a visual benefit at near and/or intermediate, such as multifocal IOLs, EDoF (Extended Depth of Focus) IOLs, enhanced monofocal IOLs, and for refractive procedures offering a visual benefit at near and/or intermediate, additional visual outcomes and safety outcomes may be assessed.

  9. Post-operative Distance Corrected Near Visual Acuity

    Time frame: postoperative visit 3-6 months

    For intraocular lens offering a visual benefit at near and/or intermediate, such as multifocal IOLs, EDoF (Extended Depth of Focus) IOLs, enhanced monofocal IOLs, and for refractive procedures offering a visual benefit at near and/or intermediate, additional visual outcomes and safety outcomes may be assessed.

  10. Post-operative Distance Corrected Intermediate Visual Acuity

    Time frame: postoperative visit 3-6 months

    For intraocular lens offering a visual benefit at near and/or intermediate, such as multifocal IOLs, EDoF (Extended Depth of Focus) IOLs, enhanced monofocal IOLs, and for refractive procedures offering a visual benefit at near and/or intermediate, additional visual outcomes and safety outcomes may be assessed.

  11. Defocus Curve

    Time frame: postoperative visit 3-6 months

    For intraocular lens offering a visual benefit at near and/or intermediate, such as multifocal IOLs, EDoF (Extended Depth of Focus) IOLs, enhanced monofocal IOLs, and for refractive procedures offering a visual benefit at near and/or intermediate, additional visual outcomes and safety outcomes may be assessed.

  12. Quality of Vision Questionnaire

    Time frame: postoperative visit 3-6 months

    For intraocular lens offering a visual benefit at near and/or intermediate, such as multifocal IOLs, EDoF (Extended Depth of Focus) IOLs, enhanced monofocal IOLs, and for refractive procedures offering a visual benefit at near and/or intermediate, additional visual outcomes and safety outcomes may be assessed.

  13. Contrast Sensitivity

    Time frame: postoperative visit 3-6 months

    For intraocular lens offering a visual benefit at near and/or intermediate, such as multifocal IOLs, EDoF (Extended Depth of Focus) IOLs, enhanced monofocal IOLs, and for refractive procedures offering a visual benefit at near and/or intermediate, additional visual outcomes and safety outcomes may be assessed.

Secondary outcomes

  1. Comparative analysis - Different types of IOLs

    Time frame: postoperative visit 3-6 months

    Comparative analysis between different types of IOLs might be performed to investigate whether one IOL might offer additional benefits to patients compared to another IOL.

  2. Comparative analysis - Refractive procedure

    Time frame: postoperative visit 3-6 months

    Comparative analysis between different types of refractive procedures might be performed to investigate whether one procedure might offer additional benefits to patients.

Other outcomes

  1. Glare Assessment

    Time frame: postoperative visit 3-6 months

    For intraocular lens offering a visual benefit at near and/or intermediate, such as multifocal IOLs, EDoF (Extended Depth of Focus) IOLs, enhanced monofocal IOLs, and additional glare perceptions may be assessed.

Study contacts

Contact information is provided by the study sponsor or research team.

Kieren Darcy, BM MRCS (Eng) CertLRS FRCOphth

CONTACT

[email protected]

+44 117 905 7722

Sponsors and collaborators

Lead sponsor

Vision Care Collective Limited

Other

Collaborators

  • Rayner Intraocular Lenses Limited

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2026
Registry last updated
Mar 18, 2026

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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