CataractNCT07168109
Visual Outcomes of an Enhanced Monofocal Intraocular Lens Targeted for Monovision in Highly Myopic Eyes: a Randomized Controlled Trial
A study testing Enhanced monofocal intraocular lens implantation (monovision strategy) and Enhanced monofocal intraocular lens implantation (bilateral myopia strategy) in people with Cataract and High Myopia, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
Trial summary
The goal of this clinical trial is to evaluate whether an enhanced monofocal intraocular lens targeted for monovision can improve visual outcomes in patients with cataract and high myopia (axial length ≥ 26 mm). Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cataract, High Myopia
- What is being tested?
- Enhanced monofocal intraocular lens implantation (monovision strategy) and Enhanced monofocal intraocular lens implantation (bilateral myopia strategy)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Jul 2027
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 85 years (inclusive), no gender restrictions;
- Scheduled to undergo bilateral phacoemulsification with intraocular lens implantation;
- Axial length ≥ 26.0 mm in both eyes;
- Desire for postoperative spectacle independence;
- Able to understand and cooperate with the trial procedures, voluntarily participate in this clinical trial, and sign an informed consent form.
Who cannot join
- Poor-quality preoperative ocular biometry (Axial length, keratometry, anterior chamber depth);
- Preoperative corneal astigmatism ≥ 1.5 diopters (D);
- Patients with intraoperative or postoperative complications (ie, intraoperative posterior capsular rupture, zonular dehiscence, secondary glaucoma, etc.);
- The presence of other ocular diseases (ie, strabismus, severe retinal pathology, uveitis, other relevant ophthalmic diseases that might affect outcomes or trauma, etc.);
- A history of intraocular surgery;
- Severe chronic systemic diseases, psychiatric disorders, dementia, hearing impairments, or mobility limitations that would interfere with understanding of the monovision design, attendance at follow-up visits, or completion of questionnaires.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The goal of this clinical trial is to evaluate whether an enhanced monofocal intraocular lens targeted for monovision can improve visual outcomes in patients with cataract and high myopia (axial length ≥ 26 mm).
The main questions it aims to answer are:
Read more
For people with cataract and high myopia, does an enhanced monofocal intraocular lens targeted for monovision provide greater binocular uncorrected distance visual acuity compared with targeting myopia in both eyes? Does an enhanced monofocal intraocular lens targeted for monovision provide comparable binocular uncorrected intermediate and near visual acuity, contrast sensitivity, reading ability, spectacle independence, stereopsis, and photic phenomena compared with targeting myopia in both eyes?
Researchers will compare an enhanced monofocal intraocular lens targeted for monovision with one targeted for myopia in both eyes to determine whether the monovision strategy is more effective.
Participants will:
Undergo phacoemulsification with enhanced monofocal intraocular lens implantation. Attend follow-up visits at 1, 3, 6, and 12 months after cataract surgery.
- Conditions
- Cataract, High Myopia
- Being tested
- Enhanced monofocal intraocular lens implantation (monovision strategy), Enhanced monofocal intraocular lens implantation (bilateral myopia strategy)
- Keywords
- high myopia, cataract, impaired visual acuity
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced monofocal intraocular lens implantation (monovision strategy)Procedure or surgery
Participants will undergo phacoemulsification with the implantation of an enhanced monofocal intraocular lens, targeting -0.5 D in the dominant eye and -2.0 D in the non-dominant eye. The first operated eye will be selected based on the worse corrected distance visual acuity; if both eyes are similar, the eye subjectively perceived by the patient as having worse vision will be chosen. The second eye surgery will be performed within 2 weeks after the first eye surgery. Ocular dominance will be determined preoperatively using the "finger method" . Intraocular lens power will be calculated using multiple formulas [Emmetropia Verifying Optical (EVO) version 2.0, Kane, LISA].
Enhanced monofocal intraocular lens implantation (bilateral myopia strategy)Procedure or surgery
Participants will undergo phacoemulsification with the implantation of an enhanced monofocal intraocular lens, targeting -2.0 D in both eyes. The first operated eye will be selected based on the worse corrected distance visual acuity; if both eyes are similar, the eye subjectively perceived by the patient as having worse vision will be chosen. The second eye surgery will be performed within 2 weeks after the first eye surgery. Ocular dominance will be determined preoperatively using the "finger method". Intraocular lens power will be calculated using multiple formulas [Emmetropia Verifying Optical (EVO) version 2.0, Kane, LISA].
| Study group | Role | What they receive |
|---|---|---|
| Monovision group | Experimental | Both eyes will be implanted with enhanced monofocal intraocular lenses, with the dominant eye targeted for -0.5 diopters (D) and the nondominant eye for -2.0 D. Receives: Procedure: Enhanced monofocal intraocular lens implantation (monovision strategy) |
| Bilateral myopia group | Active comparator | Both eyes will be implanted with enhanced monofocal intraocular lenses, with each eye targeted for -2.0 D. Receives: Procedure: Enhanced monofocal intraocular lens implantation (bilateral myopia strategy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binocular uncorrected distance visual acuity at 4 m
measured by the ETDRS chart
Measured: 3 months (±2 weeks) following the second eye surgery
Secondary outcomes (8)
Monocular and binocular uncorrected distance visual acuity at 4 m
measured by the ETDRS chart
Measured: 1, 6, 12 months following the second eye surgery
Monocular and binocular uncorrected intermediate visual acuity at 80cm and 60cm
measured by the EDTRS chart
Measured: 1, 3, 6, 12 months following the second eye surgery
Monocular and binocular uncorrected near visual acuity at 40cm
measured by the EDTRS chart
Measured: 1, 3, 6, 12 months following the second eye surgery
Monocular and binocular defocus curves
measured by the binoptometer 4P
Measured: 3, 6, 12 months following the second eye surgery
Stereoscopic vision
Measured: 3, 6, 12 months following the second eye surgery
Patient-reported outcome measures (PROMs): Vision-specific quality of life
Vision-specific quality of life is measured by the Chinese version of the 9-item short-form of the Catquest questionnaire (Catquest-9SF). There are five text response options for the answers, scaled from "Yes, very great difficulties" to "No, no difficulties", including the answer "Cannot decide". The minimum score is 9, and the maximum score is 36.
Measured: 3, 6, 12 months following the second eye surgery
Patient-reported outcome measures (PROMs): Photic phenomena
Pictures from the Quality of Vision (QoV) questionnaire were shown to patients, who were then asked to rate the frequency (never, occasionally, quite often, very often), severity (none, mild, moderate, severe) of photic phenomena and the extent to which these phenomena interfered with daily life (not at all, a little, quite, very).
Measured: 3, 6, 12 months following the second eye surgery
Patient-reported outcome measures (PROMs): Spectacle independence
Spectacle independence is measured by a self-made spectacle independence questionnaire. Patients will be asked about the frequency of spectacle independence at the distance, intermediate, and near distances. There are three text response options for the answers, including "Always", "Seldom", and "Never".
Measured: 3, 6, 12 months following the second eye surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Jul 2027 (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.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Eye Hospital
- Responsible party
- Principal investigator, Lixia Luo, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07168109
- Sponsor's protocol ID
- 2025KYPJ072
- Status last verified
- Aug 2025
- First submitted
- 2 Sep 2025
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Outcomes of an Enhanced Monofocal Intraocular Lens Targeted for Monovision in Highly Myopic Eyes: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07168109
- Acronym / sponsor ID
- 2025KYPJ072
- Conditions
- Cataract, High Myopia
- Keywords
- high myopia, cataract, impaired visual acuity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Shenzhen Eye Hospital
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 11 Sep 2025 (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.
The goal of this clinical trial is to evaluate whether an enhanced monofocal intraocular lens targeted for monovision can improve visual outcomes in patients with cataract and high myopia (axial length ≥ 26 mm).
The main questions it aims to answer are:
For people with cataract and high myopia, does an enhanced monofocal intraocular lens targeted for monovision provide greater binocular uncorrected distance visual acuity compared with targeting myopia in both eyes? Does an enhanced monofocal intraocular lens targeted for monovision provide comparable binocular uncorrected intermediate and near visual acuity, contrast sensitivity, reading ability, spectacle independence, stereopsis, and photic phenomena compared with targeting myopia in both eyes?
Researchers will compare an enhanced monofocal intraocular lens targeted for monovision with one targeted for myopia in both eyes to determine whether the monovision strategy is more effective.
Participants will:
Undergo phacoemulsification with enhanced monofocal intraocular lens implantation. Attend follow-up visits at 1, 3, 6, and 12 months after cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monovision group | Experimental | Procedure: Enhanced monofocal intraocular lens implantation (monovision strategy)Both eyes will be implanted with enhanced monofocal intraocular lenses, with the dominant eye targeted for -0.5 diopters (D) and the nondominant eye for -2.0 D. |
| Bilateral myopia group | Active comparator | Procedure: Enhanced monofocal intraocular lens implantation (bilateral myopia strategy)Both eyes will be implanted with enhanced monofocal intraocular lenses, with each eye targeted for -2.0 D. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 85 years (inclusive), no gender restrictions;
- Scheduled to undergo bilateral phacoemulsification with intraocular lens implantation;
- Axial length ≥ 26.0 mm in both eyes;
- Desire for postoperative spectacle independence;
- Able to understand and cooperate with the trial procedures, voluntarily participate in this clinical trial, and sign an informed consent form.
Key exclusion criteria (6 listed)
- Poor-quality preoperative ocular biometry (Axial length, keratometry, anterior chamber depth);
- Preoperative corneal astigmatism ≥ 1.5 diopters (D);
- Patients with intraoperative or postoperative complications (ie, intraoperative posterior capsular rupture, zonular dehiscence, secondary glaucoma, etc.);
- The presence of other ocular diseases (ie, strabismus, severe retinal pathology, uveitis, other relevant ophthalmic diseases that might affect outcomes or trauma, etc.);
- A history of intraocular surgery;
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 |
|---|---|---|
| Enhanced monofocal intraocular lens implantation (monovision strategy)Participants will undergo phacoemulsification with the implantation of an enhanced monofocal intraocular lens, targeting -0.5 D in the dominant eye and -2.0 D in the non-dominant eye. The first operated eye will be selected based on the worse corrected distance visual acuity; if both eyes are similar, the eye subjectively perceived by the patient as having worse vision will be chosen. The second eye surgery will be performed within 2 weeks after the first eye surgery. Ocular dominance will be determined preoperatively using the "finger method" . Intraocular lens power will be calculated using multiple formulas [Emmetropia Verifying Optical (EVO) version 2.0, Kane, LISA]. | Procedure or surgery | Monovision group |
| Enhanced monofocal intraocular lens implantation (bilateral myopia strategy)Participants will undergo phacoemulsification with the implantation of an enhanced monofocal intraocular lens, targeting -2.0 D in both eyes. The first operated eye will be selected based on the worse corrected distance visual acuity; if both eyes are similar, the eye subjectively perceived by the patient as having worse vision will be chosen. The second eye surgery will be performed within 2 weeks after the first eye surgery. Ocular dominance will be determined preoperatively using the "finger method". Intraocular lens power will be calculated using multiple formulas [Emmetropia Verifying Optical (EVO) version 2.0, Kane, LISA]. | Procedure or surgery | Bilateral myopia group |
Primary outcome
Binocular uncorrected distance visual acuity at 4 m
Time frame: 3 months (±2 weeks) following the second eye surgery
measured by the ETDRS chart
8 secondary outcomes
Monocular and binocular uncorrected distance visual acuity at 4 m
Time frame: 1, 6, 12 months following the second eye surgery
Monocular and binocular uncorrected intermediate visual acuity at 80cm and 60cm
Time frame: 1, 3, 6, 12 months following the second eye surgery
Monocular and binocular uncorrected near visual acuity at 40cm
Time frame: 1, 3, 6, 12 months following the second eye surgery
Monocular and binocular defocus curves
Time frame: 3, 6, 12 months following the second eye surgery
Stereoscopic vision
Time frame: 3, 6, 12 months following the second eye surgery
Patient-reported outcome measures (PROMs): Vision-specific quality of life
Time frame: 3, 6, 12 months following the second eye surgery
Patient-reported outcome measures (PROMs): Photic phenomena
Time frame: 3, 6, 12 months following the second eye surgery
Patient-reported outcome measures (PROMs): Spectacle independence
Time frame: 3, 6, 12 months following the second eye 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 18 Sep 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced monofocal intraocular lens implantation (monovision strategy) and Enhanced monofocal intraocular lens implantation (bilateral myopia strategy) in people with Cataract and High Myopia, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
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 5 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: opening soon, as of the sponsor's last update on 18 Sep 2025. 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?
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?
Contact Lixia Luo (+8618665666679, luolixia@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binocular uncorrected distance visual acuity at 4 m (time frame: 3 months (±2 weeks) following the second eye 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 18 Sep 2025.