CataractNCT04522427
Study of Presbyopia-correcting Intraocular Lenses in Eyes With Previous Corneal Refractive Surgery
A study testing Use Multifocal and Extended Depth-of-Focus Intraocular Lenses(IOLs) and Use Monofocal intraocular lenses(IOLs) in people with Cataract and Presbyopia, run by Eye & ENT Hospital of Fudan University at 1 site in China.
Trial summary
This is a single-center, randomized, open, positive product, parallel controlled trial to evaluate the clinical outcomes of presbyopia-correcting intraocular lenses(IOLs) in eyes with previous corneal refractive surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract, Presbyopia
- What is being tested?
- Use Multifocal and Extended Depth-of-Focus Intraocular Lenses(IOLs) and Use Monofocal intraocular lenses(IOLs)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2020to 31 Aug 2022
- 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
- The operated eye has ever undergone corneal refractive surgery, including PRK, LASIK, LASEK, FS-LASIK, SMILE and excluding RK
- At least one eye suffering from cataract and expected to undergo phacoemulsification and IOL implantation and cataract nuclei rigidity in the operated eye from 1 to 3 degree
- Expected to use intraocular lens power in -10.0D~+30.0D
- Willing and able to comply with scheduled visits and other study procedures.
- The need to decrease the dependence of glasses
- Signing an informed consent form
Who cannot join
- Any vision-limiting problems (e.g., corneal, retinal, infection) which could potentially limit their post-operative visual potential
- Any newly acquired ocular condition or pathology (e.g., ARMD, epiretinal membrane, chronic dry eye, irregular astigmatism, diabetic retinopathy)
- The density of corneal endothelial cells is lower than 2000/mm2
- The natural diameter of the pupil under the darkroom is less than 3mm or greater than 5.5mm
- The Kappa or Alpha angle of the operated eye is greater than 0.5mm, or the Kappa angle is greater than half of the diameter of the central refractive optical zone in the multifocal intraocular lens
- Patients with expected best corrected distance visual acuity(BCDVA) less than 0.5 (decimal vision)
Show all 23Show fewer
- Occurrence of irregular corneal astigmatism that affects postoperative vision
- Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye
- Pregnant, lactation or planning to become pregnant in the near future
- Any surgical contraindications
- Uncontrolled systemic or ocular disease
- Use of any systemic or topical drug known to interfere with visual performance
- Other ocular surgery at the time of the cataract extraction
- Traumatic cataract or congenital bilateral cataract in the operated eye
- Getting used to reading with glasses
- High requirements for visual functions in patients' career or daily life
- Professional drivers or frequent outdoor workers at night
- A medical history of photophobia
- Amblyopia
- Excessive vision expectations after surgery or too sensitive, nervous, depressed or picky
- Unsupervised or unable to comply with scheduled visits
- The contralateral eye was judged to lose visual function
- Other situations where the researcher judges that the patient is not suitable for inclusion
Trial locations and contacts
1 site in 1 country.
China1 site
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031
Yinghong Ji, phD, 18917785069, jiyh_eent@163.com
About this study
Official title: Study of Presbyopia-correcting Intraocular Lenses in Eyes With Previous Corneal Laser Refractive Surgery
This is a single-center, randomized, open, positive product, parallel controlled trial to evaluate the clinical outcomes of presbyopia-correcting intraocular lenses(IOLs) in eyes with previous corneal refractive surgery.
Specific Aim 1 (Primary): To compare the surgical successful rate of Multifocal and Extended Depth-of-Focus IOLs with Monofocal IOLs for the treatment in eyes with previous corneal refractive surgery.
Specific Aim 2 (Secondary): To study the suboptimal surgical outcomes between Multifocal and Extended Depth-of-Focus IOLs with Monofocal IOLs for the treatment in eyes with previous corneal refractive surgery.
Read the detailed description
Recently, the demands for myopia correction and corneal refractive laser surgery are rising with the increased prevalence of myopia. Corneal laser refractive surgery includes photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), laser-assisted subepithelial keratomileusis ( LASEK), femtosecond assisted laser in situ keratomileusis (FS-LASIK), and small incision lenticule extraction(SMILE). At present, FS-LASIK and SMILE are the mainstream methods for correcting myopia refractive surgery with advantages of safety, reliability, predictability and stability compared with other types of refractive surgery. Cataract is the most important cause of blindness in my country and even in the world. More than 50% of blind people are caused by cataract. Many patients who have undergone corneal laser refractive surgery may develop presbyopia or cataracts with age. Phacoemulsification and intraocular lens(IOLs) implantation are the main methods for cataract due to lacking effective pharmaceutical treatments. In addition, the patients who use traditional monofocal IOLs without the ability of accommodation may fail to get rid of glasses. Therefore, a solution that can provide both distance vision and near vision is needed to the presbyopia or cataracts patients with previous corneal refractive surgery and accustomed to taking glasses off.The application of presbyopic IOL in cataract after corneal refractive surgery become extensive with the IOL technology continuously advancing, including Extended Depth-of-Focus(EDOF) IOL, multifocal IOL(especially trifocal IOL) and so on, which can improve the distance, middle, and near visual acuity conducing to reduce the rate of wearing glasses after cataract surgery.
This project is a single-center, randomized, open, positive product, parallel controlled trial to study the clinical outcomes and applied value of presbyopic IOLs, including EDOF and trifocal IOLs after corneal laser refractive surgery complicated with cataracts, and seek better solutions to enable patients to achieve satisfactory visual quality and refractive results after surgery, culminating in completing patients' demand of taking glasses off.
- Conditions
- Cataract, Presbyopia
- Being tested
- Use Multifocal and Extended Depth-of-Focus Intraocular Lenses(IOLs), Use Monofocal intraocular lenses(IOLs)
- Keywords
- Post-corneal Refractive Surgery, Presbyopia-correcting IOL, Cataract, Efficiency, Safety
- Medical subject headings
- Cataract, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use Multifocal and Extended Depth-of-Focus Intraocular Lenses(IOLs)Device
IOLs include AT LISA tri 839MP, AcrySof IQ PanOptix IOL, TECNIS Symfony EDOF
Use Monofocal intraocular lenses(IOLs)Device
Monofocal IOLs include 409(Zeiss), AcrySof, TECNIS IOLS
| Study group | Role | What they receive |
|---|---|---|
| Multifocal and Extended Depth-of-Focus intraocular lenses | Experimental | Patients suffering from cataract getting phacoemulsification and Intraocular lenses(IOLs) implantation Receives: Device: Use Multifocal and Extended Depth-of-Focus Intraocular Lenses(IOLs) |
| Monofocal intraocular Lenses | Active comparator | Patients suffering from cataract getting phacoemulsification and Intraocular lenses(IOLs) implantation Receives: Device: Use Monofocal intraocular lenses(IOLs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative UDVA measured with standard visual acuity charts
postoperative uncorrected distance visual acuity(UDVA)
Measured: Measured 3 months after cataract surgery
Postoperative UIVA measured with standard visual acuity charts
Postoperative uncorrected intermediate visual acuity(UIVA)
Measured: Measured 3 months after cataract surgery
Postoperative UNVA measured with standard visual acuity charts
Postoperative uncorrected near visual acuity(UNVA)
Measured: Measured 3 months after cataract surgery
Secondary outcomes (10)
monocular vision measured with standard visual acuity charts
Uncorrected distance visual acuity and best corrected distance visual acuity
Measured: Measured first day, first week, first month, 3 months, and 6 months after cataract surgery
monocular vision measured with standard visual acuity charts
Uncorrected intermediate visual acuity, best corrected intermediate visual acuity, distance-corrected intermediate visual acuity, uncorrected near visual acuity, best corrected near visual acuity, and distance-corrected near visual acuity
Measured: Measured 1 month, 3 months, and 6 months after cataract surgery
Diopter measured by Phorometer
Important factor affecting the improvement of postoperative visual function
Measured: Measured 1 month, 3 months, and 6 months after cataract surgery
IOL rotation stability
The change in axis position will be evaluated with respect to the baseline measurement at the end of surgery. Differences in axis position will be described as rotation in degrees (0 to 360°)
Measured: Measured first day, first week, first month, 3 months, and 6 months after cataract surgery
Wavefront aberration measured with the iTrace (Tracey Technologies, Houston, TX)
total aberration, total low-order aberration, and total high-order aberration
Measured: Measured 1 month, 3 months, and 6 months after cataract surgery
Contrast sensitivity measured by FACT chart
Provide accurate and comprehensive objective basis for the evaluation of visual function of cataract patients
Measured: Measured 6 months after cataract surgery
Binocular vision measured with standard visual acuity charts
Uncorrected distance visual acuity, best corrected distance visual acuity, uncorrected intermediate visual acuity, best corrected intermediate visual acuity, distance-corrected intermediate visual acuity, uncorrected near visual acuity, best corrected near visual acuity, and distance-corrected near visual acuity.
Measured: Measured 6 months after cataract surgery
The rate of IOL dislocation
Effectiveness evaluation index
Measured: Measured 6 months after cataract surgery
Defocus Curve
Drawing Defocus Curve after taking the average of the data collected in each group of patients
Measured: Measured 6 months after cataract surgery
Postoperative satisfaction：Chinese version visual function index-12(VF-12-CN)
Questionnaire survey on patients' quality of life
Measured: Measured 6 months after cataract surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Eye & ENT Hospital of Fudan 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
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye & ENT Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yinghong Ji, phD, Principal investigator, Eye Institute, Eye & ENT Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04522427
- Sponsor's protocol ID
- Yinghong Ji
- Status last verified
- Aug 2020
- First submitted
- 16 Aug 2020
- Last updated
- 21 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wen D, McAlinden C, Flitcroft I, Tu R, Wang Q, Alio J, Marshall J, Huang Y, Song B, Hu L, Zhao Y, Zhu S, Gao R, Bao F, Yu A, Yu Y, Lian H, Huang J. Postoperative Efficacy, Predictability, Safety, and Visual Quality of Laser Corneal Refractive Surgery: A Network Meta-analysis. Am J Ophthalmol. 2017 Jun;178:65-78. doi: 10.1016/j.ajo.2017.03.013. Epub 2017 Mar 20.
PubMed 28336402Li M, Li M, Chen Y, Miao H, Yang D, Ni K, Zhou X. Five-year results of small incision lenticule extraction (SMILE) and femtosecond laser LASIK (FS-LASIK) for myopia. Acta Ophthalmol. 2019 May;97(3):e373-e380. doi: 10.1111/aos.14017. Epub 2019 Jan 11.
PubMed 30632671Bourne RR, Stevens GA, White RA, Smith JL, Flaxman SR, Price H, Jonas JB, Keeffe J, Leasher J, Naidoo K, Pesudovs K, Resnikoff S, Taylor HR; Vision Loss Expert Group. Causes of vision loss worldwide, 1990-2010: a systematic analysis. Lancet Glob Health. 2013 Dec;1(6):e339-49. doi: 10.1016/S2214-109X(13)70113-X. Epub 2013 Nov 11.
PubMed 25104599Tang Y, Wang X, Wang J, Huang W, Gao Y, Luo Y, Lu Y. Prevalence and Causes of Visual Impairment in a Chinese Adult Population: The Taizhou Eye Study. Ophthalmology. 2015 Jul;122(7):1480-8. doi: 10.1016/j.ophtha.2015.03.022. Epub 2015 May 16.
PubMed 25986897Keates RH, Pearce JL, Schneider RT. Clinical results of the multifocal lens. J Cataract Refract Surg. 1987 Sep;13(5):557-60. doi: 10.1016/s0886-3350(87)80114-1.
PubMed 3312575Seitz B, Langenbucher A, Nguyen NX, Kus MM, Kuchle M. Underestimation of intraocular lens power for cataract surgery after myopic photorefractive keratectomy. Ophthalmology. 1999 Apr;106(4):693-702. doi: 10.1016/S0161-6420(99)90153-7.
PubMed 10201589Chan TC, Liu D, Yu M, Jhanji V. Longitudinal evaluation of posterior corneal elevation after laser refractive surgery using swept-source optical coherence tomography. Ophthalmology. 2015 Apr;122(4):687-92. doi: 10.1016/j.ophtha.2014.10.011. Epub 2014 Dec 6.
PubMed 25487425Wang L, Hill WE, Koch DD. Evaluation of intraocular lens power prediction methods using the American Society of Cataract and Refractive Surgeons Post-Keratorefractive Intraocular Lens Power Calculator. J Cataract Refract Surg. 2010 Sep;36(9):1466-73. doi: 10.1016/j.jcrs.2010.03.044.
PubMed 20692556Ferreira TB, Pinheiro J, Zabala L, Ribeiro FJ. Comparative analysis of clinical outcomes of a monofocal and an extended-range-of-vision intraocular lens in eyes with previous myopic laser in situ keratomileusis. J Cataract Refract Surg. 2018 Feb;44(2):149-155. doi: 10.1016/j.jcrs.2017.11.007. Epub 2018 Mar 8.
PubMed 29526338Alio JL, Abdelghany AA, Abdou AA, Maldonado MJ. Cataract surgery on the previous corneal refractive surgery patient. Surv Ophthalmol. 2016 Nov-Dec;61(6):769-777. doi: 10.1016/j.survophthal.2016.07.001. Epub 2016 Jul 15.
PubMed 27423631Naseri A, McLeod SD. Cataract surgery after refractive surgery. Curr Opin Ophthalmol. 2010 Jan;21(1):35-8. doi: 10.1097/ICU.0b013e328333e9ab.
PubMed 19996749Gimbel H, Sun R, Kaye GB. Refractive error in cataract surgery after previous refractive surgery. J Cataract Refract Surg. 2000 Jan;26(1):142-4. doi: 10.1016/s0886-3350(99)00327-2.
PubMed 10646161Koch DD, Wang L. Calculating IOL power in eyes that have had refractive surgery. J Cataract Refract Surg. 2003 Nov;29(11):2039-42. doi: 10.1016/j.jcrs.2003.10.009. No abstract available.
PubMed 14670401Aramberri J. Intraocular lens power calculation after corneal refractive surgery: double-K method. J Cataract Refract Surg. 2003 Nov;29(11):2063-8. doi: 10.1016/s0886-3350(03)00957-x.
PubMed 14670413Tang M, Li Y, Huang D. An intraocular lens power calculation formula based on optical coherence tomography: a pilot study. J Refract Surg. 2010 Jun;26(6):430-7. doi: 10.3928/1081597X-20090710-02. Epub 2010 Jun 17.
PubMed 20677729
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Presbyopia-correcting Intraocular Lenses in Eyes With Previous Corneal Laser Refractive Surgery
- ClinicalTrials.gov ID
- NCT04522427
- Acronym / sponsor ID
- Yinghong Ji
- Conditions
- Cataract, Presbyopia
- Keywords
- Post-corneal Refractive Surgery, Presbyopia-correcting IOL, Cataract, Efficiency, Safety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- Eye & ENT Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 21 Aug 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.
This is a single-center, randomized, open, positive product, parallel controlled trial to evaluate the clinical outcomes of presbyopia-correcting intraocular lenses(IOLs) in eyes with previous corneal refractive surgery.
Specific Aim 1 (Primary): To compare the surgical successful rate of Multifocal and Extended Depth-of-Focus IOLs with Monofocal IOLs for the treatment in eyes with previous corneal refractive surgery.
Specific Aim 2 (Secondary): To study the suboptimal surgical outcomes between Multifocal and Extended Depth-of-Focus IOLs with Monofocal IOLs for the treatment in eyes with previous corneal refractive surgery.
Detailed description
Recently, the demands for myopia correction and corneal refractive laser surgery are rising with the increased prevalence of myopia. Corneal laser refractive surgery includes photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), laser-assisted subepithelial keratomileusis ( LASEK), femtosecond assisted laser in situ keratomileusis (FS-LASIK), and small incision lenticule extraction(SMILE). At present, FS-LASIK and SMILE are the mainstream methods for correcting myopia refractive surgery with advantages of safety, reliability, predictability and stability compared with other types of refractive surgery. Cataract is the most important cause of blindness in my country and even in the world. More than 50% of blind people are caused by cataract. Many patients who have undergone corneal laser refractive surgery may develop presbyopia or cataracts with age. Phacoemulsification and intraocular lens(IOLs) implantation are the main methods for cataract due to lacking effective pharmaceutical treatments. In addition, the patients who use traditional monofocal IOLs without the ability of accommodation may fail to get rid of glasses. Therefore, a solution that can provide both distance vision and near vision is needed to the presbyopia or cataracts patients with previous corneal refractive surgery and accustomed to taking glasses off.The application of presbyopic IOL in cataract after corneal refractive surgery become extensive with the IOL technology continuously advancing, including Extended Depth-of-Focus(EDOF) IOL, multifocal IOL(especially trifocal IOL) and so on, which can improve the distance, middle, and near visual acuity conducing to reduce the rate of wearing glasses after cataract surgery.
This project is a single-center, randomized, open, positive product, parallel controlled trial to study the clinical outcomes and applied value of presbyopic IOLs, including EDOF and trifocal IOLs after corneal laser refractive surgery complicated with cataracts, and seek better solutions to enable patients to achieve satisfactory visual quality and refractive results after surgery, culminating in completing patients' demand of taking glasses off.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifocal and Extended Depth-of-Focus intraocular lenses | Experimental | Device: Use Multifocal and Extended Depth-of-Focus Intraocular Lenses(IOLs)Patients suffering from cataract getting phacoemulsification and Intraocular lenses(IOLs) implantation |
| Monofocal intraocular Lenses | Active comparator | Device: Use Monofocal intraocular lenses(IOLs)Patients suffering from cataract getting phacoemulsification and Intraocular lenses(IOLs) implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The operated eye has ever undergone corneal refractive surgery, including PRK, LASIK, LASEK, FS-LASIK, SMILE and excluding RK
- At least one eye suffering from cataract and expected to undergo phacoemulsification and IOL implantation and cataract nuclei rigidity in the operated eye from 1 to 3 degree
- Expected to use intraocular lens power in -10.0D~+30.0D
- Willing and able to comply with scheduled visits and other study procedures.
- The need to decrease the dependence of glasses
Key exclusion criteria (23 listed)
- Any vision-limiting problems (e.g., corneal, retinal, infection) which could potentially limit their post-operative visual potential
- Any newly acquired ocular condition or pathology (e.g., ARMD, epiretinal membrane, chronic dry eye, irregular astigmatism, diabetic retinopathy)
- The density of corneal endothelial cells is lower than 2000/mm2
- The natural diameter of the pupil under the darkroom is less than 3mm or greater than 5.5mm
- The Kappa or Alpha angle of the operated eye is greater than 0.5mm, or the Kappa angle is greater than half of the diameter of the central refractive optical zone in the multifocal intraocular lens
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 |
|---|---|---|
| Use Multifocal and Extended Depth-of-Focus Intraocular Lenses(IOLs)IOLs include AT LISA tri 839MP, AcrySof IQ PanOptix IOL, TECNIS Symfony EDOF | Device | Multifocal and Extended Depth-of-Focus intraocular lenses |
| Use Monofocal intraocular lenses(IOLs)Monofocal IOLs include 409(Zeiss), AcrySof, TECNIS IOLS | Device | Monofocal intraocular Lenses |
Primary outcome
Postoperative UDVA measured with standard visual acuity charts
Time frame: Measured 3 months after cataract surgery
postoperative uncorrected distance visual acuity(UDVA)
Postoperative UIVA measured with standard visual acuity charts
Time frame: Measured 3 months after cataract surgery
Postoperative uncorrected intermediate visual acuity(UIVA)
Postoperative UNVA measured with standard visual acuity charts
Time frame: Measured 3 months after cataract surgery
Postoperative uncorrected near visual acuity(UNVA)
10 secondary outcomes
monocular vision measured with standard visual acuity charts
Time frame: Measured first day, first week, first month, 3 months, and 6 months after cataract surgery
monocular vision measured with standard visual acuity charts
Time frame: Measured 1 month, 3 months, and 6 months after cataract surgery
Diopter measured by Phorometer
Time frame: Measured 1 month, 3 months, and 6 months after cataract surgery
IOL rotation stability
Time frame: Measured first day, first week, first month, 3 months, and 6 months after cataract surgery
Wavefront aberration measured with the iTrace (Tracey Technologies, Houston, TX)
Time frame: Measured 1 month, 3 months, and 6 months after cataract surgery
Contrast sensitivity measured by FACT chart
Time frame: Measured 6 months after cataract surgery
Binocular vision measured with standard visual acuity charts
Time frame: Measured 6 months after cataract surgery
The rate of IOL dislocation
Time frame: Measured 6 months after cataract surgery
Defocus Curve
Time frame: Measured 6 months after cataract surgery
Postoperative satisfaction：Chinese version visual function index-12(VF-12-CN)
Time frame: Measured 6 months after cataract surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2020.
- Background: PubMed 28336402Wen D, McAlinden C, Flitcroft I, Tu R, Wang Q, Alio J, Marshall J, Huang Y, Song B, Hu L, Zhao Y, Zhu S, Gao R, Bao F, Yu A, Yu Y, Lian H, Huang J. Postoperative Efficacy, Predictability, Safety, and Visual Quality of Laser Corneal Refractive Surgery: A Network Meta-analysis. Am J Ophthalmol. 2017 Jun;178:65-78. doi: 10.1016/j.ajo.2017.03.013. Epub 2017 Mar 20.
- Background: PubMed 30632671Li M, Li M, Chen Y, Miao H, Yang D, Ni K, Zhou X. Five-year results of small incision lenticule extraction (SMILE) and femtosecond laser LASIK (FS-LASIK) for myopia. Acta Ophthalmol. 2019 May;97(3):e373-e380. doi: 10.1111/aos.14017. Epub 2019 Jan 11.
- Background: PubMed 25104599Bourne RR, Stevens GA, White RA, Smith JL, Flaxman SR, Price H, Jonas JB, Keeffe J, Leasher J, Naidoo K, Pesudovs K, Resnikoff S, Taylor HR; Vision Loss Expert Group. Causes of vision loss worldwide, 1990-2010: a systematic analysis. Lancet Glob Health. 2013 Dec;1(6):e339-49. doi: 10.1016/S2214-109X(13)70113-X. Epub 2013 Nov 11.
- Background: PubMed 25986897Tang Y, Wang X, Wang J, Huang W, Gao Y, Luo Y, Lu Y. Prevalence and Causes of Visual Impairment in a Chinese Adult Population: The Taizhou Eye Study. Ophthalmology. 2015 Jul;122(7):1480-8. doi: 10.1016/j.ophtha.2015.03.022. Epub 2015 May 16.
- Background: PubMed 3312575Keates RH, Pearce JL, Schneider RT. Clinical results of the multifocal lens. J Cataract Refract Surg. 1987 Sep;13(5):557-60. doi: 10.1016/s0886-3350(87)80114-1.
- Background: PubMed 10201589Seitz B, Langenbucher A, Nguyen NX, Kus MM, Kuchle M. Underestimation of intraocular lens power for cataract surgery after myopic photorefractive keratectomy. Ophthalmology. 1999 Apr;106(4):693-702. doi: 10.1016/S0161-6420(99)90153-7.
- Background: PubMed 25487425Chan TC, Liu D, Yu M, Jhanji V. Longitudinal evaluation of posterior corneal elevation after laser refractive surgery using swept-source optical coherence tomography. Ophthalmology. 2015 Apr;122(4):687-92. doi: 10.1016/j.ophtha.2014.10.011. Epub 2014 Dec 6.
- Background: PubMed 20692556Wang L, Hill WE, Koch DD. Evaluation of intraocular lens power prediction methods using the American Society of Cataract and Refractive Surgeons Post-Keratorefractive Intraocular Lens Power Calculator. J Cataract Refract Surg. 2010 Sep;36(9):1466-73. doi: 10.1016/j.jcrs.2010.03.044.
- Background: PubMed 29526338Ferreira TB, Pinheiro J, Zabala L, Ribeiro FJ. Comparative analysis of clinical outcomes of a monofocal and an extended-range-of-vision intraocular lens in eyes with previous myopic laser in situ keratomileusis. J Cataract Refract Surg. 2018 Feb;44(2):149-155. doi: 10.1016/j.jcrs.2017.11.007. Epub 2018 Mar 8.
- Background: PubMed 27423631Alio JL, Abdelghany AA, Abdou AA, Maldonado MJ. Cataract surgery on the previous corneal refractive surgery patient. Surv Ophthalmol. 2016 Nov-Dec;61(6):769-777. doi: 10.1016/j.survophthal.2016.07.001. Epub 2016 Jul 15.
- Background: PubMed 19996749Naseri A, McLeod SD. Cataract surgery after refractive surgery. Curr Opin Ophthalmol. 2010 Jan;21(1):35-8. doi: 10.1097/ICU.0b013e328333e9ab.
- Background: PubMed 10646161Gimbel H, Sun R, Kaye GB. Refractive error in cataract surgery after previous refractive surgery. J Cataract Refract Surg. 2000 Jan;26(1):142-4. doi: 10.1016/s0886-3350(99)00327-2.
- 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.
Yinghong Ji, phD principal investigator
Eye Institute, Eye & ENT Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use Multifocal and Extended Depth-of-Focus Intraocular Lenses(IOLs) and Use Monofocal intraocular lenses(IOLs) in people with Cataract and Presbyopia, run by Eye & ENT Hospital of Fudan University 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 6 inclusion and 23 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 21 Aug 2020. 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 Yinghong Ji, phD (18917785069, jiyh_eent@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative UDVA measured with standard visual acuity charts (time frame: Measured 3 months after cataract surgery). The study lists 3 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 NCT04522427, which also lists 17 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 21 Aug 2020.