Revised Capsular Polishing and Its Impact on the Positioning of the Intraocular Lens and Visual Quality Following Femtosecond Laser-assisted Cataract Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cataract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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polished

The polished group did the improved capsular polishing.

Group Type ACTIVE_COMPARATOR

improved capsular polishing

Intervention Type PROCEDURE

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.

control

The control group did not undergo improved polishing, the conventional I/A polishing the capsule instead.

Group Type PLACEBO_COMPARATOR

the conventional I/A polishing

Intervention Type PROCEDURE

the conventional I/A polishing the capsule

Interventions

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improved capsular polishing

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.

Intervention Type PROCEDURE

the conventional I/A polishing

the conventional I/A polishing the capsule

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Diagnosed with age-related cataract
2. 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
3. Anticipated postoperative astigmatism of ≤1.00D
4. Pupil diameter in a darkened environment ranging from 3.0-5.5 mm
5. Kappa angle ≤0.5 mm or less than half the diameter of the central refractive optical zone of the MIOL.

Exclusion Criteria

1. 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
2. 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
3. Severe mental and psychological diseases
4. History of internal eye surgery
5. Posterior capsule rupture or uneventful in-the-bag IOL implantation

Minimum Eligible Age

50 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No