CataractNCT04265820
Prospective Clinical Study of Unilateral or Bilateral Implantation of Intraocular Lens in Cataract Patients
A study testing unilateral implantation of IOL and bilateral implantation of IOL in people with Cataract, run by Peking University Third Hospital at 1 site in China.
Trial summary
This is to evaluate the satisfaction of patient and postoperative functional vision of unilateral or bilateral Implantation of intraocular lens（IOLs） in cataract patients. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cataract
- What is being tested?
- unilateral implantation of IOL and bilateral implantation of IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2019to 1 Aug 2020
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with unilateral or bilateral age related cataracts
- 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
This is to evaluate the satisfaction of patient and postoperative functional vision of unilateral or bilateral Implantation of intraocular lens（IOLs） in cataract patients.
Read the detailed description
The subjects will undergo uneventful phacoemulsification and implantation of IOL.
The subjects will be divided into two groups . The unilateral cataract patients in the Group 1 will undergo unilateral surgery, and the bilateral cataract patients in the Group 2 will undergo bilateral surgery. IOL may be monofocal,bifocal ,or trifocal，according to the patients preference and the eyes condition. In each group, the subjects will be divided into three subgroups according to the type of the IOLs.Compare binocular functional vision and the satisfaction of patient between the two groups at postoperative 3 months.Compare binocular functional vision and the satisfaction of patient with different IOLs among the subgroups.
- Conditions
- Cataract
- Being tested
- unilateral implantation of IOL, bilateral implantation of IOL
- Keywords
- unilateral cataract, binocular functional vision, Multifocal Intraocular Lenses
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unilateral implantation of IOLDevice
unilateral phacoemulsification and implantation of IOL.IOL may be monofocal,bifocal ,or trifocal，according to the patients preference and the eyes condition.
bilateral implantation of IOLDevice
bilateral phacoemulsification and implantation of IOL.IOL may be monofocal,bifocal ,or trifocal，according to the patients preference and the eyes condition.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | The unilateral cataract patients in the Group 1 will undergo phacoemulsification and unilateral implantation of IOLs.The subjects will be divided into three subgroups according to the type of the IOLs. Receives: Device: unilateral implantation of IOL |
| Group 2 | Active comparator | The bilateral cataract patients in the Group 2 will undergo phacoemulsification and bilateral implantation of IOLs.The subjects will be divided into three subgroups according to the type of the IOLs. Receives: Device: bilateral implantation of 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
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
Use block diagram of random-spot synoptophore to observe long distance stereopsis vision and yan's stereogram to observe short distance stereopsis vision.
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
Photic phenomena (score according to severity,0~4, higher scores mean worse)and spectacle dependence percentages will be evaluated by 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 start28 Oct 2019
- Primary completion1 May 2020 (estimated)
- Study completion1 Aug 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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Qi Hong, PhD，MD, Study director, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265820
- Sponsor's protocol ID
- 20191126
- Status last verified
- Feb 2020
- First submitted
- 26 Nov 2019
- Last updated
- 12 Feb 2020
- 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 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study of Unilateral or Bilateral Implantation of Intraocular Lens in Cataract Patients
- ClinicalTrials.gov ID
- NCT04265820
- Acronym / sponsor ID
- 20191126
- Conditions
- Cataract
- Keywords
- unilateral cataract, binocular functional vision, Multifocal Intraocular Lenses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 28 Oct 2019 (actual)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 1 Aug 2020 (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.
This is to evaluate the satisfaction of patient and postoperative functional vision of unilateral or bilateral Implantation of intraocular lens（IOLs） in cataract patients.
Detailed description
The subjects will undergo uneventful phacoemulsification and implantation of IOL.
The subjects will be divided into two groups . The unilateral cataract patients in the Group 1 will undergo unilateral surgery, and the bilateral cataract patients in the Group 2 will undergo bilateral surgery. IOL may be monofocal,bifocal ,or trifocal，according to the patients preference and the eyes condition. In each group, the subjects will be divided into three subgroups according to the type of the IOLs.Compare binocular functional vision and the satisfaction of patient between the two groups at postoperative 3 months.Compare binocular functional vision and the satisfaction of patient with different IOLs among the subgroups.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Device: unilateral implantation of IOLThe unilateral cataract patients in the Group 1 will undergo phacoemulsification and unilateral implantation of IOLs.The subjects will be divided into three subgroups according to the type of the IOLs. |
| Group 2 | Active comparator | Device: bilateral implantation of IOLThe bilateral cataract patients in the Group 2 will undergo phacoemulsification and bilateral implantation of IOLs.The subjects will be divided into three subgroups according to the type of the IOLs. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with unilateral or bilateral age related cataracts
- 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 |
|---|---|---|
| unilateral implantation of IOLunilateral phacoemulsification and implantation of IOL.IOL may be monofocal,bifocal ,or trifocal，according to the patients preference and the eyes condition. | Device | Group 1 |
| bilateral implantation of IOLbilateral phacoemulsification and implantation of IOL.IOL may be monofocal,bifocal ,or trifocal，according to the patients preference and the eyes condition. | Device | Group 2 |
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
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 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Cataract
Recruiting
Implementing AI-based Glaucoma Screening Within Federally Qualified Health Centers
Glaucoma, Ocular Hypertension
Not yet recruiting
Trial to Investigate the Safety and Effectiveness of the KI-362-US1 (YP2.2VM) Intraocular Lens (IOL) in Adult Participants for Correction of Aphakia Following Cataract Extraction
Aphakia, Postcataract
Not yet recruiting
Effects of Oxygen Cage Support During Cataract Surgery
Cataract
Active, not recruitingObservational study
Age-Related Eye Disease Study (AREDS) Follow-Up
Age-Related Macular Degeneration, Cataract
RecruitingObservational study
Objective Depth-of-Focus Changes During Light Adjustable Lens UV Adjustments
Light Adjustable Lens, Objective Depth of Focus
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?
A study testing unilateral implantation of IOL and bilateral implantation of IOL in people with Cataract, 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 Feb 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 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). 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 12 Feb 2020.