Outcomes of Cataract & Refractive Procedures

NCT07481487 | Recruiting

• 1 other identifier: DrDarcy_RefractiveDatabase
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Visual Correction; Refractive Surgery; Cataract Surgery

Keywords

cataract; IOL

Outcome Measures

Primary Outcomes (13)

• Post-operative Uncorrected Distance Visual Acuity

  postoperative visit 3-6 months

• Post-operative Distance Corrected Visual Acuity

  postoperative visit 3-6 months

• Post-operative subjective refraction (Sphere, Cylinder, Axis)

  postoperative visit 3-6 months

• Accuracy of post-operative refraction achieved compared to targeted refraction

  postoperative visit 3-6 months

• Loss of best-corrected visual acuity compared to preoperatively

  postoperative visit 3-6 months

• Occurrence of surgical complications and post-operative complications

  postoperative visit 3-6 months

• Post-operative Uncorrected Near Visual Acuity

  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.

  postoperative visit 3-6 months

• Post-operative Uncorrected Intermediate Visual Acuity

  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.

  postoperative visit 3-6 months

• Post-operative Distance Corrected Near Visual Acuity

  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.

  postoperative visit 3-6 months

• Post-operative Distance Corrected Intermediate Visual Acuity

  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.

  postoperative visit 3-6 months

• Defocus Curve

  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.

  postoperative visit 3-6 months

• Quality of Vision Questionnaire

  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.

  postoperative visit 3-6 months

• Contrast Sensitivity

  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.

  postoperative visit 3-6 months

Secondary Outcomes (2)

• Comparative analysis - Different types of IOLs

  postoperative visit 3-6 months

• Comparative analysis - Refractive procedure

  postoperative visit 3-6 months

Other Outcomes (1)

• Glare Assessment

  postoperative visit 3-6 months

Study Arms (1)

Patient of the clinic

The population for the database will be existing patients of the clinic. These are patients who presented to the clinic with an interest for a refractive or cataract procedure.

Eligibility Criteria

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

Study Population

The population for the database will be existing patients of the clinic. These are patients who presented to the clinic with an interest for a refractive or cataract procedure.

You may qualify if:

• 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

You may not qualify if:

• NONE

Sponsors & Collaborators

• Vision Care Collective Limited: lead
• Rayner Intraocular Lenses Limited: collaborator

Study Sites (1)

Vision Care Clinic Bristol

Bristol, England, BS8 1BN, United Kingdom

RECRUITING

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Central Study Contacts

Kieren Darcy, BM MRCS (Eng) CertLRS FRCOphth

CONTACT

+44 117 905 7722; contact@visioncareclinic.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BM MRCS (Eng) CertLRS FRCOphth MBA

Study Record Dates

• First Submitted: March 13, 2026
• First Posted: March 18, 2026
• Study Start: April 15, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Locations

GB (1)