Clinical trial NCT06517095: Revised Capsular Polishing and Its Impact on the Positioning of the Intraocular Lens and Visual Quality Following Femtosecond Laser-assisted Cataract Surgery
Official title: Revised Capsular Polishing and Its Impact on the Positioning of the Intraocular Lens and Visual Quality Following Femtosecond Laser-assisted Cataract Surgery
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cataract
Keywords: visual acuity
visual quality
polishing
femtosecond laser
Lead sponsor: Xi'an People's Hospital (Xi'an Fourth Hospital)
Sponsor class: OTHER
First posted: 2024-07-24
Enrollment: 0
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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

Primary outcomes:
measure: visual acuity
timeFrame: 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.
measure: strehl ratio(SR)
timeFrame: 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.
measure: modulation transfer function cutoff frequency (MTF cutoff)
timeFrame: 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.
measure: objective scatter index (OSI)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xin Zhou
state: Shaanxi
Study officials:
References: