CataractNCT02825693
Femtosecond Laser Assisted Cataract Surgery in The NHS
A study testing Conventional cataract surgery (phacoemulsification) and Femtosecond laser assisted cataract surgery in people with Cataract and Surgery, run by Guy's and St Thomas' NHS Foundation Trust.
Trial summary
This study aims to examine the health economic impact of adopting femtosecond laser technology to assist high volume cataract surgery (FLACS) within a state-funded healthcare system, the National Health Service (NHS). Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Conventional cataract surgery (phacoemulsification) and Femtosecond laser assisted cataract surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have reduced visual acuity or visual symptoms attributed to the presence of cataract in one or both eyes by the examining ophthalmologist or else must require cataract surgery on clinical grounds other than visual symptoms.
- Patients must be willing to attend for follow-up at 1 month after cataract surgery.
- Patients must be sufficiently fluent in English for informed consent and self-completion of the patient reported outcome questionnaires.
Who cannot join
- Children below the age of 18
- Already enrolled in another study
- The principle exclusion criteria relate to clinical contraindications for FLACS, such as:
- Significant corneal opacities
- Small pupils following pharmacological dilatation
- Patients unable to lie sufficiently flat so as to be positioned underneath the laser machine.
About this study
Official title: The Development of Surgical Pathways Using Femto-second Laser Technology to Increase the Efficiency and Safety of Cataract Surgery Within a Public Health Sector Setting - A Randomised Controlled Trial
This study aims to examine the health economic impact of adopting femtosecond laser technology to assist high volume cataract surgery (FLACS) within a state-funded healthcare system, the National Health Service (NHS).
- Being tested
- Conventional cataract surgery (phacoemulsification), Femtosecond laser assisted cataract surgery
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional cataract surgery (phacoemulsification)Procedure or surgery
Femtosecond laser assisted cataract surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Femtosecond laser cataract surgery | Active comparator | Cataract surgery with femtosecond laser treatment for corneal incisions, astigmatic keratotomies, capsulotomy and nuclear fragmentation Receives: Procedure: Femtosecond laser assisted cataract surgery |
| Conventional phacoemulsification surgery | Active comparator | Conventional phacoemulsification surgery Receives: Procedure: Conventional cataract surgery (phacoemulsification) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost-analysis: Healthcare resource use attributable to managing patients in this study will be collected.
These include (but not necessarily be limited to) the cost of surgery for both arms of the trial (including resource use and staffing levels required for the surgical protocols), resource use attributable to managing complications arising from surgery, all relevant diagnostic investigations, further surgery where necessary, hospital length of stay and ward type, outpatient attendances, procedures performed on an outpatient basis, Accident \& Emergency attendances and prescribed drug medications. The quantity of resource use for each cost component will be measured from medical records. Site-specific unit costs will be taken in preference of standard published sources or national tariffs where possible.
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2017
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Guy's and St Thomas' NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02825693
- Sponsor's protocol ID
- ILH297-P002
- Status last verified
- Feb 2020
- First submitted
- 20 Jun 2016
- Last updated
- 23 Jul 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Surgical Pathways Using Femto-second Laser Technology to Increase the Efficiency and Safety of Cataract Surgery Within a Public Health Sector Setting - A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02825693
- Acronym / sponsor ID
- ILH297-P002
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to examine the health economic impact of adopting femtosecond laser technology to assist high volume cataract surgery (FLACS) within a state-funded healthcare system, the National Health Service (NHS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femtosecond laser cataract surgery | Active comparator | Procedure: Femtosecond laser assisted cataract surgeryCataract surgery with femtosecond laser treatment for corneal incisions, astigmatic keratotomies, capsulotomy and nuclear fragmentation |
| Conventional phacoemulsification surgery | Active comparator | Procedure: Conventional cataract surgery (phacoemulsification)Conventional phacoemulsification surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have reduced visual acuity or visual symptoms attributed to the presence of cataract in one or both eyes by the examining ophthalmologist or else must require cataract surgery on clinical grounds other than visual symptoms.
- Patients must be willing to attend for follow-up at 1 month after cataract surgery.
- Patients must be sufficiently fluent in English for informed consent and self-completion of the patient reported outcome questionnaires.
Key exclusion criteria (6 listed)
- Children below the age of 18
- Already enrolled in another study
- Significant corneal opacities
- Small pupils following pharmacological dilatation
- Patients unable to lie sufficiently flat so as to be positioned underneath the laser machine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional cataract surgery (phacoemulsification) | Procedure or surgery | Conventional phacoemulsification surgery |
| Femtosecond laser assisted cataract surgery | Procedure or surgery | Femtosecond laser cataract surgery |
Primary outcome
Cost-analysis: Healthcare resource use attributable to managing patients in this study will be collected.
Time frame: up to 2 months
These include (but not necessarily be limited to) the cost of surgery for both arms of the trial (including resource use and staffing levels required for the surgical protocols), resource use attributable to managing complications arising from surgery, all relevant diagnostic investigations, further surgery where necessary, hospital length of stay and ward type, outpatient attendances, procedures performed on an outpatient basis, Accident \& Emergency attendances and prescribed drug medications. The quantity of resource use for each cost component will be measured from medical records. Site-specific unit costs will be taken in preference of standard published sources or national tariffs where possible.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional cataract surgery (phacoemulsification) and Femtosecond laser assisted cataract surgery in people with Cataract and Surgery, run by Guy's and St Thomas' NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost-analysis: Healthcare resource use attributable to managing patients in this study will be collected. (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.