PresbyopiaNCT04265846
Prospective Clinical Study of Different Intraocular Lens Implantation Designed for the Correction of Presbyopia
An observational study of Presbyopia and Cataract Senile, run by Peking University Third Hospital at 1 site in China.
Trial summary
Compare postoperative Subjective and objective visual quality and economic efficiency of different Intraocular Lens(IOLs) implantation designed for the correction of presbyopia. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Presbyopia, Cataract Senile
- What is being tested?
- bifocal IOL, mix bifocal IOL and trifocal IOL
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2020to 1 Nov 2022
- Phase
- Observational
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with bilateral cataract
Who may be able to join
- Patients with bilateral cataract
- Regular corneal topography and Preoperative corneal astigmatism ≤ 0.75 Diopter
Who cannot join
- Pregnant or nursing women
- In the presence of other ocular diseases that may affect the stability of the lens capsule (pseudoexfoliation syndrome, glaucoma, traumatic cataract, Marfan syndrome, etc.)
- Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)
- History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerv atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) in the study eyes that could alter or limit final postoperative visual prognosis.
- Patients with history of ocular trauma or prior ocular surgery including refractive procedures
- postoperative visual acuity of worse than 0.2 logMAR in any eye
- Patients using systemic or ocular medication that affect visual acuity.
- Patients participating in other clinical trials during the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Hong Qi, MD, doctorqihong@163.com
About this study
Compare postoperative Subjective and objective visual quality and economic efficiency of different Intraocular Lens(IOLs) implantation designed for the correction of presbyopia.
Read the detailed description
Compare postoperative Subjective and objective visual quality and economic efficiency of different Intraocular Lens Implantation designed for the correction of presbyopia.The subjects will undergo bilateral uneventful phacoemulsification and implantation of IOL.The subjects will be divided into several groups according to the type of the IOLs，including monofocal IOL group,monovision designed group ，bifocal IOL group, mix bifocal IOL group，trifocal IOL group，Exteded Depth of Focus(EDOF) IOL group and blend vision group. Compare the Subjective and objective visual quality and economic efficiency among these groups at 3 months postoperatively.
- Conditions
- Presbyopia, Cataract Senile
- Being tested
- bifocal IOL, mix bifocal IOL, trifocal IOL, EDOF IOL, different IOLs
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bifocal IOLDevice
The patients will undergo bilateral phacoemulsification and bifocal IOLs implantation.
mix bifocal IOLDevice
The patients will undergo phacoemulsification and mix different bifocal IOLs implantation bilaterally.
trifocal IOLDevice
The patients will undergo bilateral phacoemulsification and trifocal IOLs implantation.
EDOF IOLDevice
The patients will undergo bilateral phacoemulsification and EDOF IOLs implantation.
different IOLsDevice
The patients will undergo phacoemulsification and different IOLs implantation bilaterally.
monofocal IOLDevice
The patients will undergo bilateral phacoemulsification and monofocal IOLs implantation with monovision designed.
monofocal IOLDevice
The patients will undergo bilateral phacoemulsification and monofocal IOLs implantation with emmetropia designed.
| Study group | Role | What they receive |
|---|---|---|
| bifocal IOL group | The cataract patients who ask for bilateral phacoemulsification and bifocal IOLs implantation. Receives: Device: bifocal IOL | |
| mix bifocal IOL group | The cataract patients who ask for phacoemulsification and mix different bifocal IOLs implantation bilaterally Receives: Device: mix bifocal IOL | |
| trifocal IOL group | The cataract patients who ask for bilateral phacoemulsification and trifocal IOLs implantation. Receives: Device: trifocal IOL | |
| EDOF IOL group | The cataract patients who ask for bilateral phacoemulsification and EDOF IOLs implantation. Receives: Device: EDOF IOL | |
| blend vision group | The cataract patients who ask for phacoemulsification and different IOLs implantation bilaterally. Receives: Device: different IOLs | |
| monovision designed group | The cataract patients who ask for bilateral phacoemulsification and monofocal IOLs implantation with monovision designed. Receives: Device: monofocal IOL | |
| monofocal IOL group | The cataract patients who ask for bilateral phacoemulsification and monofocal IOLs implantation with emmetropia designed. Receives: Device: monofocal IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
monocular and binocular visual acuity
uncorrected distance visual acuity (UCVA), intermediate visual acuity, near visual acuity will be measured at 5m, 80cm and 40cm respectively. All visual acuity measurements will be conducted under photopic conditions (85 cd/m2) and at 100% contrast
Measured: 3 months postoperatively
economic efficiency
economic efficiency was defined as the ratio of objective spectacle independence (UCVA better than 0.10 logMAR) and IOL price, then compare the economic efficiency among different groups.
Measured: 3 months postoperatively
Secondary outcomes (5)
Binocular Contrast sensitivity
Contrast sensitivity measures will be conducted binocularly, under photopic, mesopic (5 cd/m2), photopic with glare and mesopic with glare conditions, with the OPTEC 6500 contrast sensitivity test (Stereo Optical, USA). Contrast sensitivity will be evaluated at five spatial frequencies (1.5, 3, 6, 12, and 18 cycles per degree [cpd]). Patients will be allowed 5 minutes to adapt to each illumination level before testing.
Measured: 3 months postoperatively
Binocular Defocus Curve
Binocular defocus curves will be obtained in all patients, positioned at 5m under photopic (>85 cd/m 2 ) condition to measure the visual acuity with each defocus lens, representing the consecutive visual function of each eye. Negative lenses were added in 0.50 D steps and the visual acuity will be recorded for each type of defocus level. The procedure will be then repeated but with positive lenses. The range of defocus evaluated is from -4.00D to +2.00D.
Measured: 3 months postoperatively
stereopsis
distant stereopsis will be measured by block diagram of random-spot synoptophore, while near stereopsis will be measured by Yan's stereogram.
Measured: 3 months postoperatively
Fusion function
The fusion function of perception and movement (convergence and divergence)will be examined with a synoptophore.
Measured: 3 months postoperatively
Subjective visual quality
Using NEI-VFQ-25 questionnaire (Chinese version). Photic phenomena, spectacle independence, and satisfaction questionnaire.
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start31 May 2020
- Primary completion31 May 2022
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- People's Hospital of Guangxi Zhuang Autonomous Region
- Responsible party
- Sponsor
- Investigators
- Qi Hong, PhD，MD, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265846
- Sponsor's protocol ID
- 20191129
- Status last verified
- Mar 2022
- First submitted
- 29 Nov 2019
- Last updated
- 12 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sun T, Zhao X, Liu Y, Lan Q, Tang C, Qin R, Bian L, Li W, Qi H. Neurosensory binocular vision after bilateral implantation of an extended depth of focus intraocular lens with micro-monovision: a prospective cohort study. BMC Ophthalmol. 2025 May 19;25(1):294. doi: 10.1186/s12886-025-04125-5.
PubMed 40389895Sun T, Liu Y, Gao Y, Tang C, Lan Q, Yang T, Zhao X, Qi H. Comparison of visual outcomes of a diffractive trifocal intraocular lens and a refractive bifocal intraocular lens in eyes with axial myopia: a prospective cohort study. BMC Ophthalmol. 2022 Oct 20;22(1):407. doi: 10.1186/s12886-022-02626-1.
PubMed 36266642Lan Q, Liu Y, Xu F, Li M, Li Y, Yang T, Sun T, Yao G, Ma B, Tao L, Xiao X, Feng XL, Zeng S, Qi H. Cost-Effectiveness of Presbyopia Correction Among Seven Strategies of Bilateral Cataract Surgery Based on a Prospective Single-Blind Two-Center Trial in China. Ophthalmol Ther. 2022 Dec;11(6):2067-2082. doi: 10.1007/s40123-022-00562-3. Epub 2022 Sep 7.
PubMed 36071311
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study of Different Intraocular Lens Implantation Designed for the Correction of Presbyopia
- ClinicalTrials.gov ID
- NCT04265846
- Acronym / sponsor ID
- 20191129
- Conditions
- Presbyopia, Cataract Senile
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- People's Hospital of Guangxi Zhuang Autonomous Region
- Study start
- 31 May 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 12 Feb 2020 (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.
Compare postoperative Subjective and objective visual quality and economic efficiency of different Intraocular Lens(IOLs) implantation designed for the correction of presbyopia.
Detailed description
Compare postoperative Subjective and objective visual quality and economic efficiency of different Intraocular Lens Implantation designed for the correction of presbyopia.The subjects will undergo bilateral uneventful phacoemulsification and implantation of IOL.The subjects will be divided into several groups according to the type of the IOLs，including monofocal IOL group,monovision designed group ，bifocal IOL group, mix bifocal IOL group，trifocal IOL group，Exteded Depth of Focus(EDOF) IOL group and blend vision group. Compare the Subjective and objective visual quality and economic efficiency among these groups at 3 months postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| bifocal IOL group | – | Device: bifocal IOLThe cataract patients who ask for bilateral phacoemulsification and bifocal IOLs implantation. |
| mix bifocal IOL group | – | Device: mix bifocal IOLThe cataract patients who ask for phacoemulsification and mix different bifocal IOLs implantation bilaterally |
| trifocal IOL group | – | Device: trifocal IOLThe cataract patients who ask for bilateral phacoemulsification and trifocal IOLs implantation. |
| EDOF IOL group | – | Device: EDOF IOLThe cataract patients who ask for bilateral phacoemulsification and EDOF IOLs implantation. |
| blend vision group | – | Device: different IOLsThe cataract patients who ask for phacoemulsification and different IOLs implantation bilaterally. |
| monovision designed group | – | Device: monofocal IOLThe cataract patients who ask for bilateral phacoemulsification and monofocal IOLs implantation with monovision designed. |
| monofocal IOL group | – | Device: monofocal IOLThe cataract patients who ask for bilateral phacoemulsification and monofocal IOLs implantation with emmetropia designed. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with bilateral cataract
Key inclusion criteria (2 listed)
- Patients with bilateral cataract
- Regular corneal topography and Preoperative corneal astigmatism ≤ 0.75 Diopter
Key exclusion criteria (8 listed)
- Pregnant or nursing women
- In the presence of other ocular diseases that may affect the stability of the lens capsule (pseudoexfoliation syndrome, glaucoma, traumatic cataract, Marfan syndrome, etc.)
- Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)
- History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy optic nerv atrophy, amblyopia, strabismus, microphthalmos, aniridia, epiretinal membrane etc.) in the study eyes that could alter or limit final postoperative visual prognosis.
- Patients with history of ocular trauma or prior ocular surgery including refractive procedures
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 |
|---|---|---|
| bifocal IOLThe patients will undergo bilateral phacoemulsification and bifocal IOLs implantation. | Device | bifocal IOL group |
| mix bifocal IOLThe patients will undergo phacoemulsification and mix different bifocal IOLs implantation bilaterally. | Device | mix bifocal IOL group |
| trifocal IOLThe patients will undergo bilateral phacoemulsification and trifocal IOLs implantation. | Device | trifocal IOL group |
| EDOF IOLThe patients will undergo bilateral phacoemulsification and EDOF IOLs implantation. | Device | EDOF IOL group |
| different IOLsThe patients will undergo phacoemulsification and different IOLs implantation bilaterally. | Device | blend vision group |
| monofocal IOLThe patients will undergo bilateral phacoemulsification and monofocal IOLs implantation with monovision designed. | Device | monovision designed group |
| monofocal IOLThe patients will undergo bilateral phacoemulsification and monofocal IOLs implantation with emmetropia designed. | Device | monofocal IOL group |
Primary outcome
monocular and binocular visual acuity
Time frame: 3 months postoperatively
uncorrected distance visual acuity (UCVA), intermediate visual acuity, near visual acuity will be measured at 5m, 80cm and 40cm respectively. All visual acuity measurements will be conducted under photopic conditions (85 cd/m2) and at 100% contrast
economic efficiency
Time frame: 3 months postoperatively
economic efficiency was defined as the ratio of objective spectacle independence (UCVA better than 0.10 logMAR) and IOL price, then compare the economic efficiency among different groups.
5 secondary outcomes
Binocular Contrast sensitivity
Time frame: 3 months postoperatively
Binocular Defocus Curve
Time frame: 3 months postoperatively
stereopsis
Time frame: 3 months postoperatively
Fusion function
Time frame: 3 months postoperatively
Subjective visual quality
Time frame: 3 months postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2022.
- Derived from this study: PubMed 40389895Sun T, Zhao X, Liu Y, Lan Q, Tang C, Qin R, Bian L, Li W, Qi H. Neurosensory binocular vision after bilateral implantation of an extended depth of focus intraocular lens with micro-monovision: a prospective cohort study. BMC Ophthalmol. 2025 May 19;25(1):294. doi: 10.1186/s12886-025-04125-5.
- Derived from this study: PubMed 36266642Sun T, Liu Y, Gao Y, Tang C, Lan Q, Yang T, Zhao X, Qi H. Comparison of visual outcomes of a diffractive trifocal intraocular lens and a refractive bifocal intraocular lens in eyes with axial myopia: a prospective cohort study. BMC Ophthalmol. 2022 Oct 20;22(1):407. doi: 10.1186/s12886-022-02626-1.
- Derived from this study: PubMed 36071311Lan Q, Liu Y, Xu F, Li M, Li Y, Yang T, Sun T, Yao G, Ma B, Tao L, Xiao X, Feng XL, Zeng S, Qi H. Cost-Effectiveness of Presbyopia Correction Among Seven Strategies of Bilateral Cataract Surgery Based on a Prospective Single-Blind Two-Center Trial in China. Ophthalmol Ther. 2022 Dec;11(6):2067-2082. doi: 10.1007/s40123-022-00562-3. Epub 2022 Sep 7.
- 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.
Qi Hong, PhD，MD study director
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Presbyopia and Cataract Senile, run by Peking University Third Hospital at 1 site in China.
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 2 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: status not confirmed, as of the sponsor's last update on 12 Aug 2022. 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 China. 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.
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 Qianqian Lan (+8618607711972, 54283122@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
monocular and binocular visual acuity (time frame: 3 months postoperatively). 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?
On the ClinicalTrials.gov record for NCT04265846, which also lists 3 linked publications.
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 12 Aug 2022.