CataractNCT01654159
Assessment of Visual Function and Optics in Intraocular Lenses
A study testing Monofocal IOL, Multifocal IOL and Toric IOL in people with Cataract, run by Aston University at 1 site in United Kingdom.
Trial summary
The main objective of this research is to assess visual function and optical performance of CE marked, implanted intraocular lenses to understand the individual factors that affect their performance and how these may be improved in future designs and to evaluate measurement techniques. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Cataract
- What is being tested?
- Monofocal IOL, Multifocal IOL and Toric IOL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2013to 30 Nov 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects age between 40-85 years, may be either male or female, and may be of any race (as cataracts rarely occur before the age of 40 and above 85 other ocular pathology is common).
- Subjects requiring cataract surgery.
- Potential for best corrected visual acuity of 6/12 or better (as visual function in these patients will be affected by ocular pathology).
- Subjects with clear intraocular media other than cataract (as assessing cataract).
- General physical and mental condition allowing participation in current study.
- Subjects willing to participate as evidenced by signing the written informed
Who cannot join
- Prior surgery on the selected eye
- Previous uveitis or trauma to the selected eye, anterior or posterior synechiae
- Potential for best corrected visual acuity worse than 6/12 (since this may indicate other causes of ocular pathology)
- Partial or total paralysis, Parkinsons syndrome, cerebrovascular accident or other condition that could impact on the results of the study
- Subject over 85 years of age (ocular pathology more common in this age group)
- Subjects without adequate physical and mental capacity to enable participation in the study
- Subject unwilling to participate
- Systemic or topical medication known to influence visual function measures
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Birmingham Midland Eye Centre
Birmingham, West Midlands, B18 7QH
About this study
Official title: Evaluating Subjective and Objective Performance of Instrumentation Used and Devices Implanted in Cataract Surgery
The main objective of this research is to assess visual function and optical performance of CE marked, implanted intraocular lenses to understand the individual factors that affect their performance and how these may be improved in future designs and to evaluate measurement techniques.
All outcome measures will be captured 3-6 months after surgery
Read the detailed description
A cataract occurs when the natural lens of the eye, which plays a major role in the focusing of light and production of sharp visual images, becomes cloudy and hardens, resulting in a loss of visual function. Left untreated, cataracts can cause preventable blindness. During cataract surgery the natural lens is removed and a man-made intraocular lens (IOL) is implanted in its place.
IOL technology has advanced significantly in recent years and as a result the main goal of cataract surgery is no longer simply the successful removal of the cloudy lens and restoration of vision. Providing patients with the best possible refractive outcome and the best possible visual quality is now much more important when assessing surgery outcomes.
Aspheric, multifocal and accommodating IOLs are among the new designs developed to improve visual outcome after cataract surgery. In order to assess the effectiveness of these designs, visual function needs to be evaluated both objectively and subjectively following their implantation. Such evaluation allows the continued evolution of these IOL designs towards optimum. This proposed research study, which aims to assess the visual function and optical performance of new CE marked IOLs after implantation, could significantly contribute to the enhancement and development of improved IOL designs in the future.
We have successfully conducted similar patient trials for the past 5 years. As new IOL designs are constantly being developed, approved and CE marked, this type of research study will always have the potential to offer new information that is not currently available and has not previously been assessed or published and could contribute towards improved IOL designs in the future.
All outcome measures will be captured 3-6 months after surgery
- Conditions
- Cataract
- Being tested
- Monofocal IOL, Multifocal IOL, Toric IOL
- Keywords
- intraocular lenses, evaluation, cataract
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monofocal IOLProcedure or surgery
Also called Alcon AMO B&L Lenstec Oculentis Ophthec Physiol & Zeiss
Monofocal Intraocular lens will be implanted
Multifocal IOLProcedure or surgery
Multifocal IOL will be implanted
Toric IOLProcedure or surgery
Toric IOLS will be implanted
| Study group | Role | What they receive |
|---|---|---|
| Monofocal | Placebo comparator | Monofocal IOL Implant
Manufacturers of IOLs used as monofocal comparator are Alcon, AMO, Bausch and Lomb, Lenstec, Oculentis, Ophthec, Physiol and Zeiss Receives: Procedure: Monofocal IOL |
| Multifocal | Experimental | Multifocal IOL
Manufacturers of multifocal IOLs under investigation are Alcon, AMO, Bausch and Lomb, Lenstec, Oculentis, Ophthec, Physiol and Zeiss Receives: Procedure: Multifocal IOL |
| Toric | Experimental | Toric IOL
Manufacturers of toric IOLs under investigation are Alcon, AMO, Bausch and Lomb, Lenstec, Oculentis, Ophthec, Physiol and Zeiss Receives: Procedure: Toric IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unaided distance and near vision
Visual Acuity (logMAR)
Measured: Measured at 3-6 months after surgery
Secondary outcomes (4)
Patient Satisfaction
NAVQ score
Measured: Measured at 3-6 months after surgery
Residual refraction
Autorefraction / subjective refraction
Measured: Measured at 3-6 months after surgery
Aberrations
Aberrometry
Measured: Measured at 3-6 months after surgery
Corrected distance and near acuity
Acuity (logMAR)
Measured: Measured at 3-6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startSep 2013
- Primary completion30 Nov 2030 (estimated)
- Study completion30 Nov 2030 (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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aston University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunil Shah, FRCS, Principal investigator, Birmingham Midland Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654159
- Sponsor's protocol ID
- IOL2012
- Status last verified
- Jan 2026
- First submitted
- 17 Jul 2012
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data collaboration will be considered on request
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Subjective and Objective Performance of Instrumentation Used and Devices Implanted in Cataract Surgery
- ClinicalTrials.gov ID
- NCT01654159
- Acronym / sponsor ID
- IOL2012
- Conditions
- Cataract
- Keywords
- intraocular lenses, evaluation, cataract
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Aston UniversityUniversity, hospital or other
- Study start
- Sep 2013 (actual)
- Primary completion
- 30 Nov 2030 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 31 Jul 2012 (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.
The main objective of this research is to assess visual function and optical performance of CE marked, implanted intraocular lenses to understand the individual factors that affect their performance and how these may be improved in future designs and to evaluate measurement techniques.
All outcome measures will be captured 3-6 months after surgery
Detailed description
A cataract occurs when the natural lens of the eye, which plays a major role in the focusing of light and production of sharp visual images, becomes cloudy and hardens, resulting in a loss of visual function. Left untreated, cataracts can cause preventable blindness. During cataract surgery the natural lens is removed and a man-made intraocular lens (IOL) is implanted in its place.
IOL technology has advanced significantly in recent years and as a result the main goal of cataract surgery is no longer simply the successful removal of the cloudy lens and restoration of vision. Providing patients with the best possible refractive outcome and the best possible visual quality is now much more important when assessing surgery outcomes.
Aspheric, multifocal and accommodating IOLs are among the new designs developed to improve visual outcome after cataract surgery. In order to assess the effectiveness of these designs, visual function needs to be evaluated both objectively and subjectively following their implantation. Such evaluation allows the continued evolution of these IOL designs towards optimum. This proposed research study, which aims to assess the visual function and optical performance of new CE marked IOLs after implantation, could significantly contribute to the enhancement and development of improved IOL designs in the future.
We have successfully conducted similar patient trials for the past 5 years. As new IOL designs are constantly being developed, approved and CE marked, this type of research study will always have the potential to offer new information that is not currently available and has not previously been assessed or published and could contribute towards improved IOL designs in the future.
All outcome measures will be captured 3-6 months after surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Monofocal | Placebo comparator | Procedure: Monofocal IOLMonofocal IOL Implant Manufacturers of IOLs used as monofocal comparator are Alcon, AMO, Bausch and Lomb, Lenstec, Oculentis, Ophthec, Physiol and Zeiss |
| Multifocal | Experimental | Procedure: Multifocal IOLMultifocal IOL Manufacturers of multifocal IOLs under investigation are Alcon, AMO, Bausch and Lomb, Lenstec, Oculentis, Ophthec, Physiol and Zeiss |
| Toric | Experimental | Procedure: Toric IOLToric IOL Manufacturers of toric IOLs under investigation are Alcon, AMO, Bausch and Lomb, Lenstec, Oculentis, Ophthec, Physiol and Zeiss |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects age between 40-85 years, may be either male or female, and may be of any race (as cataracts rarely occur before the age of 40 and above 85 other ocular pathology is common).
- Subjects requiring cataract surgery.
- Potential for best corrected visual acuity of 6/12 or better (as visual function in these patients will be affected by ocular pathology).
- Subjects with clear intraocular media other than cataract (as assessing cataract).
- General physical and mental condition allowing participation in current study.
Key exclusion criteria (8 listed)
- Prior surgery on the selected eye
- Previous uveitis or trauma to the selected eye, anterior or posterior synechiae
- Potential for best corrected visual acuity worse than 6/12 (since this may indicate other causes of ocular pathology)
- Partial or total paralysis, Parkinsons syndrome, cerebrovascular accident or other condition that could impact on the results of the study
- Subject over 85 years of age (ocular pathology more common in this age group)
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 |
|---|---|---|
| Monofocal IOLAlso: Alcon AMO B&L Lenstec Oculentis Ophthec Physiol & ZeissMonofocal Intraocular lens will be implanted | Procedure or surgery | Monofocal |
| Multifocal IOLMultifocal IOL will be implanted | Procedure or surgery | Multifocal |
| Toric IOLToric IOLS will be implanted | Procedure or surgery | Toric |
Primary outcome
Unaided distance and near vision
Time frame: Measured at 3-6 months after surgery
Visual Acuity (logMAR)
4 secondary outcomes
Patient Satisfaction
Time frame: Measured at 3-6 months after surgery
Residual refraction
Time frame: Measured at 3-6 months after surgery
Aberrations
Time frame: Measured at 3-6 months after surgery
Corrected distance and near acuity
Time frame: Measured at 3-6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes. Data collaboration will be considered on request
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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.
Sunil Shah, FRCS principal investigator
Birmingham Midland Eye Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Monofocal IOL, Multifocal IOL and Toric IOL in people with Cataract, run by Aston University 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 6 inclusion and 8 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: enrolling by invitation, as of the sponsor's last update on 21 Jan 2026. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Unaided distance and near vision (time frame: Measured at 3-6 months after surgery). 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 21 Jan 2026.