CataractELPVQFLACSNCT06517095
Revised Capsular Polishing and Its Impact on the Positioning of the Intraocular Lens and Visual Quality Following Femtosecond Laser-assisted Cataract Surgery
A study testing improved capsular polishing and the conventional I/A polishing in people with Cataract, run by Xi'an People's Hospital (Xi'an Fourth Hospital) at 1 site in China.
Trial summary
This study aims to investigate the impact of improved capsular polishing on the long-term stability of effective lens position (ELP) and visual quality in patients following femtosecond laser-assisted cataract surgery combined with intraocular lens implantation. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cataract
- What is being tested?
- improved capsular polishing and the conventional I/A polishing
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to Dec 2025
- 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
- Diagnosed with age-related cataract
- Patients seeking to reduce their reliance on corrective eyewear postoperative and exhibiting high expectations for optimal visual acuity at all distances - near, intermediate, and distant
- Anticipated postoperative astigmatism of ≤1.00D
- Pupil diameter in a darkened environment ranging from 3.0-5.5 mm
- Kappa angle ≤0.5 mm or less than half the diameter of the central refractive optical zone of the MIOL.
Who cannot join
- Progressive and aggravated retinal diseases, such as diabetic retinopathy, macular degeneration, preretinal membrane, vitreous macular traction syndrome, Stargardt disease, retinitis pigmentosa, etc., and serious optic nerve diseases
- Small eyeballs, ultra-high myopia, obvious pupil abnormalities, severe corneal lesions, severe irregular astigmatism, chronic uveitis, glaucoma, obvious abnormalities of lens capsule membrane and suspension ligament, major degree alternating strabismus and other ocular organic diseases and amblyopia
- Severe mental and psychological diseases
- History of internal eye surgery
- Posterior capsule rupture or uneventful in-the-bag IOL implantation
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to investigate the impact of improved capsular polishing on the long-term stability of effective lens position (ELP) and visual quality in patients following femtosecond laser-assisted cataract surgery combined with intraocular lens implantation. Throughout the follow-up period, changes in ELP were observed using OCT to measure the central corneal posterior surface to the IOL anterior surface. The contraction of the anterior capsule orifice was assessed through anterior segment photography, and its diameter and area were measured and analyzed using drawing software at each follow-up visit. Additionally, the investigators analyzed the correlation between the degree of anterior capsule orifice contraction and ELP, as well as examined whether ACO formed and its degree, PCO formation and its degree. Objective examination using OQAS II was conducted to measure PSF, MTF, OSI, and SR of patients; high-order aberrations including astigmatism, trifolium, and spherical aberration were measured by OPD-Scan III. Furthermore, the investigators investigated the correlation between ACO/PCO degrees and visual quality.
- Conditions
- Cataract
- Being tested
- improved capsular polishing, the conventional I/A polishing
- Keywords
- visual acuity, visual quality, polishing, femtosecond laser
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
improved capsular polishingProcedure or surgery
In the polished group,utilize the OVDs to partially fill the peripheral capsule, causing the central posterior capsule to bulge, and then employ the double-ended Whitman Shepherd capsular polisher to meticulously polish both the anterior and equator of the capsule. This process also allows for simultaneous polishing of a portion of the posterior capsule. By rotating the polisher 180°along one side, followed by switching ends to cover the remaining 180° range, even the main incision site can be effectively addressed due to its curved tip design.
the conventional I/A polishingProcedure or surgery
the conventional I/A polishing the capsule
| Study group | Role | What they receive |
|---|---|---|
| polished | Active comparator | The polished group did the improved capsular polishing. Receives: Procedure: improved capsular polishing |
| control | Placebo comparator | The control group did not undergo improved polishing, the conventional I/A polishing the capsule instead. Receives: Procedure: the conventional I/A polishing |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
Utilize decimal visual acuity charts for assessment purposes and record the findings in LogMAR format to facilitate statistical analysis.
Measured: The data were collected at various time points for follow-up: preoperative, 1-day postoperative, 1-week postoperative, 1-month postoperative, 3-month postoperative, 6-month postoperative, and 1-year postoperative.
strehl ratio(SR)
This is one of the visual quality indicators. It's assessed by OQAS II instrument. SR that represents the ratio of the central peak value of the point spread function in an aberration-free system to that in a aberration system with the same pupil diameter, the higher the value is, the better the optical quality is.
Measured: The data were collected at various time points for follow-up: preoperative, 1-day postoperative, 1-week postoperative, 1-month postoperative, 3-month postoperative, 6-month postoperative, and 1-year postoperative.
modulation transfer function cutoff frequency (MTF cutoff)
MTF cutoff that characterizes the spatial frequency corresponding to the minimum resolution of human eyes in the modulation transfer function curve, and the higher the value is, the better the optical quality becomes,and it is immune to subjective factors and provides an objective assessment of the optical imaging quality across the entire refractive system of the artificial lens eye.
Measured: The data were collected at various time points for follow-up: preoperative, 1-day postoperative, 1-week postoperative, 1-month postoperative, 3-month postoperative, 6-month postoperative, and 1-year postoperative.
objective scatter index (OSI)
OSI that objectively reflects the scatter of the refractive medium,a higher OSI ratio indicates a more severe degree of scatter in the patient.
Measured: The data were collected at various time points for follow-up: preoperative, 1-day postoperative, 1-week postoperative, 1-month postoperative, 3-month postoperative, 6-month postoperative, and 1-year postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start1 Jan 2023
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: Conflict of interest
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.
- 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
- Model description
- The intervening measure is utilize the OVDs to partially fill the peripheral capsule, causing the central posterior capsule to bulge, and then employ the double-ended Whitman Shepherd capsular polisher to meticulously polish both the anterior and equator of the capsule. By rotating the polisher 180°along one side, followed by switching ends to cover the remaining 180° range, even the main incision site can be effectively addressed due to its curved tip design.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xi'an People's Hospital (Xi'an Fourth Hospital)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xin Zhou, Xi'an People's Hospital (Xi'an Fourth Hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06517095
- Sponsor's protocol ID
- 20150824
- Acronym
- ELPVQFLACS
- Status last verified
- Sep 2024
- First submitted
- 18 Jul 2024
- Last updated
- 24 Sep 2024
- 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 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Revised Capsular Polishing and Its Impact on the Positioning of the Intraocular Lens and Visual Quality Following Femtosecond Laser-assisted Cataract Surgery
- ClinicalTrials.gov ID
- NCT06517095
- Acronym / sponsor ID
- ELPVQFLACS / 20150824
- Conditions
- Cataract
- Keywords
- visual acuity, visual quality, polishing, femtosecond laser
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Conflict of interest
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Xi'an People's Hospital (Xi'an Fourth Hospital)University, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 24 Jul 2024 (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 study aims to investigate the impact of improved capsular polishing on the long-term stability of effective lens position (ELP) and visual quality in patients following femtosecond laser-assisted cataract surgery combined with intraocular lens implantation. Throughout the follow-up period, changes in ELP were observed using OCT to measure the central corneal posterior surface to the IOL anterior surface. The contraction of the anterior capsule orifice was assessed through anterior segment photography, and its diameter and area were measured and analyzed using drawing software at each follow-up visit. Additionally, the investigators analyzed the correlation between the degree of anterior capsule orifice contraction and ELP, as well as examined whether ACO formed and its degree, PCO formation and its degree. Objective examination using OQAS II was conducted to measure PSF, MTF, OSI, and SR of patients; high-order aberrations including astigmatism, trifolium, and spherical aberration were measured by OPD-Scan III. Furthermore, the investigators investigated the correlation between ACO/PCO degrees and visual quality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- The intervening measure is utilize the OVDs to partially fill the peripheral capsule, causing the central posterior capsule to bulge, and then employ the double-ended Whitman Shepherd capsular polisher to meticulously polish both the anterior and equator of the capsule. By rotating the polisher 180°along one side, followed by switching ends to cover the remaining 180° range, even the main incision site can be effectively addressed due to its curved tip design.
| Arm | Type | Receives |
|---|---|---|
| polished | Active comparator | Procedure: improved capsular polishingThe polished group did the improved capsular polishing. |
| control | Placebo comparator | Procedure: the conventional I/A polishingThe control group did not undergo improved polishing, the conventional I/A polishing the capsule instead. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with age-related cataract
- Patients seeking to reduce their reliance on corrective eyewear postoperative and exhibiting high expectations for optimal visual acuity at all distances - near, intermediate, and distant
- Anticipated postoperative astigmatism of ≤1.00D
- Pupil diameter in a darkened environment ranging from 3.0-5.5 mm
- Kappa angle ≤0.5 mm or less than half the diameter of the central refractive optical zone of the MIOL.
Key exclusion criteria (5 listed)
- Progressive and aggravated retinal diseases, such as diabetic retinopathy, macular degeneration, preretinal membrane, vitreous macular traction syndrome, Stargardt disease, retinitis pigmentosa, etc., and serious optic nerve diseases
- Small eyeballs, ultra-high myopia, obvious pupil abnormalities, severe corneal lesions, severe irregular astigmatism, chronic uveitis, glaucoma, obvious abnormalities of lens capsule membrane and suspension ligament, major degree alternating strabismus and other ocular organic diseases and amblyopia
- Severe mental and psychological diseases
- History of internal eye surgery
- Posterior capsule rupture or uneventful in-the-bag IOL implantation
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 |
|---|---|---|
| improved capsular polishingIn the polished group,utilize the OVDs to partially fill the peripheral capsule, causing the central posterior capsule to bulge, and then employ the double-ended Whitman Shepherd capsular polisher to meticulously polish both the anterior and equator of the capsule. This process also allows for simultaneous polishing of a portion of the posterior capsule. By rotating the polisher 180°along one side, followed by switching ends to cover the remaining 180° range, even the main incision site can be effectively addressed due to its curved tip design. | Procedure or surgery | polished |
| the conventional I/A polishingthe conventional I/A polishing the capsule | Procedure or surgery | control |
Primary outcome
visual acuity
Time frame: The data were collected at various time points for follow-up: preoperative, 1-day postoperative, 1-week postoperative, 1-month postoperative, 3-month postoperative, 6-month postoperative, and 1-year postoperative.
Utilize decimal visual acuity charts for assessment purposes and record the findings in LogMAR format to facilitate statistical analysis.
strehl ratio(SR)
Time frame: The data were collected at various time points for follow-up: preoperative, 1-day postoperative, 1-week postoperative, 1-month postoperative, 3-month postoperative, 6-month postoperative, and 1-year postoperative.
This is one of the visual quality indicators. It's assessed by OQAS II instrument. SR that represents the ratio of the central peak value of the point spread function in an aberration-free system to that in a aberration system with the same pupil diameter, the higher the value is, the better the optical quality is.
modulation transfer function cutoff frequency (MTF cutoff)
Time frame: The data were collected at various time points for follow-up: preoperative, 1-day postoperative, 1-week postoperative, 1-month postoperative, 3-month postoperative, 6-month postoperative, and 1-year postoperative.
MTF cutoff that characterizes the spatial frequency corresponding to the minimum resolution of human eyes in the modulation transfer function curve, and the higher the value is, the better the optical quality becomes,and it is immune to subjective factors and provides an objective assessment of the optical imaging quality across the entire refractive system of the artificial lens eye.
objective scatter index (OSI)
Time frame: The data were collected at various time points for follow-up: preoperative, 1-day postoperative, 1-week postoperative, 1-month postoperative, 3-month postoperative, 6-month postoperative, and 1-year postoperative.
OSI that objectively reflects the scatter of the refractive medium,a higher OSI ratio indicates a more severe degree of scatter in the patient.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing improved capsular polishing and the conventional I/A polishing in people with Cataract, run by Xi'an People's Hospital (Xi'an Fourth 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 5 inclusion and 5 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: withdrawn, as of the sponsor's last update on 24 Sep 2024. 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. Some participants in this study may receive a placebo. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual acuity (time frame: The data were collected at various time points for follow-up: preoperative, 1-day postoperative, 1-week postoperative, 1-month postoperative, 3-month postoperative, 6-month postoperative, and 1-year postoperative.). The study lists 4 primary outcomes in all. 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 24 Sep 2024.