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

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Xi'an People's Hospital (Xi'an Fourth Hospital)

Status

Withdrawn

Conditions

Cataract

Treatments

Procedure: improved capsular polishing
Procedure: the conventional I/A polishing

Study type

Interventional

Funder types

Other

Identifiers

NCT06517095
20150824

Details and patient eligibility

About

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.

Sex

All

Ages

50 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

0 participants in 2 patient groups, including a placebo group

polished
Active Comparator group
Description:
The polished group did the improved capsular polishing.
Treatment:
Procedure: improved capsular polishing
control
Placebo Comparator group
Description:
The control group did not undergo improved polishing, the conventional I/A polishing the capsule instead.
Treatment:
Procedure: the conventional I/A polishing

Trial contacts and locations

1

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Central trial contact

Xin Zhou, master

Data sourced from clinicaltrials.gov

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