CataractPhase 4NCT03819582
Visual Performance With a Hydrophobic Aspheric Monofocal IOL
A Phase 4 study testing EyeCee One intraocular lens in people with Cataract, run by University of Plymouth at 1 site in United Kingdom.
Trial summary
Artificial lenses, otherwise known as intraocular lenses (IOLs), are used to replace the natural crystalline lens within the eye during cataract or refractive lens surgery. Monofocal IOLs are the traditional IOL type used during cataract surgery. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Cataract
- What is being tested?
- EyeCee One intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2018to 1 Jan 2020
- Phase
- Phase 4
- 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 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Clinically significant Cataract requiring cataract surgery
Who cannot join
- Amblyopia
- Corneal astigmatism of >1.00D
- Dilated pupil size smaller than 5mm
- Macular pathology
- Glaucoma
- Retinal disease
Show all 11Show fewer
- Corneal disease
- Abnormal iris
- Pupil deformation
- Any previous corneal or intraocular surgery
- Any patient who had surgical complications will also be excluded from participation in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
BMI Southend Hospital
Westcliff-on-Sea, Essex, SS0 9AG
Elizabeth Law, elizabeth.law@plymouth.ac.uk
About this study
Official title: Visual Performance Following Implantation of a Hydrophobic Aspheric Monofocal Intraocular Lens
Artificial lenses, otherwise known as intraocular lenses (IOLs), are used to replace the natural crystalline lens within the eye during cataract or refractive lens surgery. Monofocal IOLs are the traditional IOL type used during cataract surgery. These monofocal IOLs provide excellent distance vision, however spectacles are required for reading and intermediate distance tasks. Monofocal Intraocular lenses are the mainstay of cataract surgery, but with advancing technologies and a wider selection of lenses available, demand for improved outcomes, improved lens design and ease of surgical implantation have increased. The purpose of this study is to assess the visual performance of the EyeCee One monofocal intraocular lens. In addition an assessment of the ease of insertion by the surgeon will be quantified.
Read the detailed description
Artificial lenses, otherwise known as intraocular lenses (IOLs), are used to replace the natural crystalline lens within the eye during cataract or refractive lens surgery. Monofocal IOLs are the traditional IOL type used during cataract surgery. These monofocal IOLs provide excellent distance vision, however spectacles are required for reading and intermediate distance tasks. There are many different designs of monofocal IOLs, all with their own unique optical properties, however there is little evidence to support which optical design provides the best visual outcome. This research project allows us to assess the visual outcomes of a specific monofocal IOL. It also allows us to assess the ease of use of the lens to the surgeon.
Each subject will be evaluated at two visits following IOL implantation; visit 1 (1 month post implantation), Visit 2 (3 months post implantation).
At both post-operative visits the patient will undergo:
Refraction Uncorrected and best corrected distance and near visual acuity measurement Optical biometry to assess ELP Slit lamp biomicroscopy to assess for post-operative complications
At the time of surgery, the ophthalmic surgeon will complete a questionnaire, detailing lens insertion time and ease of use.
- Conditions
- Cataract
- Being tested
- EyeCee One intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EyeCee One intraocular lensDevice
Hydrophobic aspheric monofocal intraocular lens
| Study group | Role | What they receive |
|---|---|---|
| Intraocular lens | Experimental | Subjects implanted with the EyeCee One Intraocular lens Receives: Device: EyeCee One intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity early post operative
Visual acuity measured in LogMAR early post operatively
Measured: 1 month post operatively
Visual acuity after 3 months post operatively
Visual acuity measured in LogMAR measured 3 months post operatively
Measured: 3 months post operatively
Secondary outcomes (1)
Ease of use to surgeons
Questionnaire completed by the surgeon to determine the usability of the intraocular lens
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2019
- Study start1 Feb 2018
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Jan 2020 (estimated)
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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Phillip J Buckhurst, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03819582
- Sponsor's protocol ID
- 17/WM/0181
- Status last verified
- Jan 2019
- First submitted
- 22 Jan 2019
- Last updated
- 28 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Performance Following Implantation of a Hydrophobic Aspheric Monofocal Intraocular Lens
- ClinicalTrials.gov ID
- NCT03819582
- Acronym / sponsor ID
- 17/WM/0181
- Conditions
- Cataract
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Jan 2020 (estimated)
- First posted
- 28 Jan 2019 (actual)
- 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.
Artificial lenses, otherwise known as intraocular lenses (IOLs), are used to replace the natural crystalline lens within the eye during cataract or refractive lens surgery. Monofocal IOLs are the traditional IOL type used during cataract surgery. These monofocal IOLs provide excellent distance vision, however spectacles are required for reading and intermediate distance tasks. Monofocal Intraocular lenses are the mainstay of cataract surgery, but with advancing technologies and a wider selection of lenses available, demand for improved outcomes, improved lens design and ease of surgical implantation have increased. The purpose of this study is to assess the visual performance of the EyeCee One monofocal intraocular lens. In addition an assessment of the ease of insertion by the surgeon will be quantified.
Detailed description
Artificial lenses, otherwise known as intraocular lenses (IOLs), are used to replace the natural crystalline lens within the eye during cataract or refractive lens surgery. Monofocal IOLs are the traditional IOL type used during cataract surgery. These monofocal IOLs provide excellent distance vision, however spectacles are required for reading and intermediate distance tasks. There are many different designs of monofocal IOLs, all with their own unique optical properties, however there is little evidence to support which optical design provides the best visual outcome. This research project allows us to assess the visual outcomes of a specific monofocal IOL. It also allows us to assess the ease of use of the lens to the surgeon.
Each subject will be evaluated at two visits following IOL implantation; visit 1 (1 month post implantation), Visit 2 (3 months post implantation).
At both post-operative visits the patient will undergo:
Refraction Uncorrected and best corrected distance and near visual acuity measurement Optical biometry to assess ELP Slit lamp biomicroscopy to assess for post-operative complications
At the time of surgery, the ophthalmic surgeon will complete a questionnaire, detailing lens insertion time and ease of use.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraocular lens | Experimental | Device: EyeCee One intraocular lensSubjects implanted with the EyeCee One Intraocular lens |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Clinically significant Cataract requiring cataract surgery
Key exclusion criteria (11 listed)
- Amblyopia
- Corneal astigmatism of >1.00D
- Dilated pupil size smaller than 5mm
- Macular pathology
- Glaucoma
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 |
|---|---|---|
| EyeCee One intraocular lensHydrophobic aspheric monofocal intraocular lens | Device | Intraocular lens |
Primary outcome
Visual acuity early post operative
Time frame: 1 month post operatively
Visual acuity measured in LogMAR early post operatively
Visual acuity after 3 months post operatively
Time frame: 3 months post operatively
Visual acuity measured in LogMAR measured 3 months post operatively
1 secondary outcome
Ease of use to surgeons
Time frame: During surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2019.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing EyeCee One intraocular lens in people with Cataract, run by University of Plymouth at 1 site in United Kingdom.
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 1 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 28 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Phillip Buckhurst (07825429121, phillip.buckhurst@plymouth.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity early post operative (time frame: 1 month post operatively). The study lists 2 primary outcomes in all. 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 28 Jan 2019; AzTrials last refreshed its copy on 2 Nov 2026.