Cataract SenileNCT04266847
Prospective Clinical Study of Preoperative and Postoperative Unilateral Mild Cataract Patients
A study testing monofocal IOL,bifocal IOL,or trifocal IOL in people with Cataract Senile, run by Peking University Third Hospital at 1 site in China.
Trial summary
This is to compare preoperative and postoperative binocular functional vision in patients with unilateral intraocular len（IOL） in one eye and mild cataract in the fellow eye. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cataract Senile
- What is being tested?
- monofocal IOL,bifocal IOL,or trifocal IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2019to 1 Sep 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 who had monocular intraocular lens in one eye with mild cataract in the fellow eye ask for the cataract surgery in the fellow eye
- Regular corneal topography and 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.)
- In the presence of other ocular diseases that is expected to have a poor final visual acuity of worse than 0.2 logMAR after surgery (amblyopia, strabismus, keratoconus, etc.)
- Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)
- Patients using systemic or ocular medication that affect visual acuity.
- Patients with history of ocular trauma or prior ocular surgery including refractive procedures
- 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 compare preoperative and postoperative binocular functional vision in patients with unilateral intraocular len（IOL） in one eye and mild cataract in the fellow eye.
Read the detailed description
The subjects are the patients who underwent monocular IOL implantation before and present mild cataract in the fellow eye.Compare preoperative and postoperative the binocular functional vision and the satisfaction of patients when the patients ask for the surgery (phacoemulsification and IOLs implantation)on the fellow eye. The type of IOLs maybe according to the patients preference and the eyes condition.The subjects will be divided into three groups according to the type of the IOLs，including monofocal group,bifocal group,and trifocal group.
- Conditions
- Cataract Senile
- Being tested
- monofocal IOL,bifocal IOL,or trifocal IOL
- Keywords
- unilateral cataract, binocular functional vision, Multifocal Intraocular Lenses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
monofocal IOL,bifocal IOL,or trifocal IOLDevice
phacoemulsification and implantation of IOL.IOL may be monofocal IOL,bifocal IOL,or trifocal IOL
| Study group | Role | What they receive |
|---|---|---|
| unilateral mild cataract patients | Experimental | The patients who underwent monocular IOL implantation before and then present mild cataract in the fellow eye. Receives: Device: monofocal IOL,bifocal IOL,or trifocal IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 start30 Oct 2019
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cataract SenileStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 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
- NCT04266847
- Sponsor's protocol ID
- 20191127
- Status last verified
- Feb 2020
- First submitted
- 29 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 Preoperative and Postoperative Unilateral Mild Cataract Patients
- ClinicalTrials.gov ID
- NCT04266847
- Acronym / sponsor ID
- 20191127
- Conditions
- Cataract Senile
- Keywords
- unilateral cataract, binocular functional vision, Multifocal Intraocular Lenses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Sep 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 compare preoperative and postoperative binocular functional vision in patients with unilateral intraocular len（IOL） in one eye and mild cataract in the fellow eye.
Detailed description
The subjects are the patients who underwent monocular IOL implantation before and present mild cataract in the fellow eye.Compare preoperative and postoperative the binocular functional vision and the satisfaction of patients when the patients ask for the surgery (phacoemulsification and IOLs implantation)on the fellow eye. The type of IOLs maybe according to the patients preference and the eyes condition.The subjects will be divided into three groups according to the type of the IOLs，including monofocal group,bifocal group,and trifocal group.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| unilateral mild cataract patients | Experimental | Device: monofocal IOL,bifocal IOL,or trifocal IOLThe patients who underwent monocular IOL implantation before and then present mild cataract in the fellow eye. |
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 who had monocular intraocular lens in one eye with mild cataract in the fellow eye ask for the cataract surgery in the fellow eye
- Regular corneal topography and corneal astigmatism ≤ 0.75 Diopter
Key exclusion criteria (7 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.)
- In the presence of other ocular diseases that is expected to have a poor final visual acuity of worse than 0.2 logMAR after surgery (amblyopia, strabismus, keratoconus, etc.)
- Pupil abnormality (non-reactive pupil, tonic pupils, abnormally shaped pupils, etc.)
- Patients using systemic or ocular medication that affect visual acuity.
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 IOL,bifocal IOL,or trifocal IOLphacoemulsification and implantation of IOL.IOL may be monofocal IOL,bifocal IOL,or trifocal IOL | Device | unilateral mild cataract patients |
Primary outcome
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
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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?
A study testing monofocal IOL,bifocal IOL,or trifocal IOL in people with 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 7 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?
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.