Outcomes of Cataract & Refractive Procedures

March 13, 2026 updated by: Kieren Darcy, Vision Care Collective Limited
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
    • England
      • Bristol, England, United Kingdom, BS8 1BN
        • Recruiting
        • Vision Care Clinic Bristol
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Post-operative Uncorrected Distance Visual Acuity
Time Frame: postoperative visit 3-6 months
postoperative visit 3-6 months
Post-operative Distance Corrected Visual Acuity
Time Frame: postoperative visit 3-6 months
postoperative visit 3-6 months
Post-operative subjective refraction (Sphere, Cylinder, Axis)
Time Frame: postoperative visit 3-6 months
postoperative visit 3-6 months
Accuracy of post-operative refraction achieved compared to targeted refraction
Time Frame: postoperative visit 3-6 months
postoperative visit 3-6 months
Loss of best-corrected visual acuity compared to preoperatively
Time Frame: postoperative visit 3-6 months
postoperative visit 3-6 months
Occurrence of surgical complications and post-operative complications
Time Frame: postoperative visit 3-6 months
postoperative visit 3-6 months
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.
postoperative visit 3-6 months
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.
postoperative visit 3-6 months
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.
postoperative visit 3-6 months
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.
postoperative visit 3-6 months
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.
postoperative visit 3-6 months
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.
postoperative visit 3-6 months
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.
postoperative visit 3-6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
postoperative visit 3-6 months
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.
postoperative visit 3-6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
postoperative visit 3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Vision Care Collective Limited

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rayner Intraocular Lenses Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 13, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DrDarcy_RefractiveDatabase

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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