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.

Study Overview

• Status: Recruiting
• Conditions: Refractive Surgery; Cataract Surgery; Visual Correction

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Kieren Darcy, BM MRCS (Eng) CertLRS FRCOphth; Phone Number: +44 117 905 7722; Email: contact@visioncareclinic.com

Study Locations

• United Kingdom
  • England
    • Bristol, England, United Kingdom, BS8 1BN
      • Recruiting
      • Vision Care Clinic Bristol
      • Contact: Kieren Darcy, BM MRCS (Eng) CertLRS FRCOphth; Phone Number: +44 117 905 7722; Email: contact@visioncareclinic.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparative analysis - Different types of IOLs	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.	postoperative visit 3-6 months
Comparative analysis - Refractive procedure	Comparative analysis between different types of refractive procedures might be performed to investigate whether one procedure might offer additional benefits to patients.	postoperative visit 3-6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glare Assessment	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.	postoperative visit 3-6 months

Collaborators and Investigators

• Sponsor: Vision Care Collective Limited
• Collaborators: Rayner Intraocular Lenses Limited

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026

Study Registration Dates

• First Submitted: March 13, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 18, 2026

Study Record Updates

• Last Update Posted (Actual): March 18, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: cataract; IOL
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: DrDarcy_RefractiveDatabase