Clinical Trials Directory

Trials / Unknown

UnknownNCT05255796

IOL-capsular Complex After Different Intraocular Lenses Implantation in Patients With High Myopia

Influence of Different Intraocular Lenses on IOL-capsular Complex After Cataract Surgery in Patients With High Myopia: a Clinical Observation Based on SS-OCT

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
40 (estimated)
Sponsor
Wenzhou Medical University · Academic / Other
Sex
All
Age
18 Years – 90 Years
Healthy volunteers
Not accepted

Summary

The IOL-capsular complex is formed after cataract surgery and intraocular lens (IOL) implantation. Early postoperative mechanical wrapping of the anterior and posterior capsules plays a significant role in preventing IOL decentration and tilt, as well as formation of the IOL-capsular complex which reduces the incidence of posterior cataract opacity. IOL decentration ≥ 0.4 mm or/and IOL tilt ≥7degree were considered clinically significant cause of poor post-surgery visual quality especially for optical sophisticated IOLs. This negative impact does not affect various types of IOLs equally. Several studies indicated that AL was an independent risk factor of IOL decentration and tilt for emmetropic or moderate myopic eyes. For patients with high myopia, they often have a longer axial length and a larger capsule diameter, which reduces the rotational stability of the IOL and may lead to tilt, decentration and displacement of IOL. Currently, there is no literature guidance to compare the results of cataract surgery combined various types of IOLs implantation in patients with high myopia. The novel anterior segment optical coherence tomography (AS-OCT) device, CASIA2 can evaluate the IOL capsule bending and the lens position after cataract surgery. Also, CASIA2 can be used to documented the dynamic changes of IOL-capsular complex after surgery.

Detailed description

The IOL-capsular complex is formed after cataract surgery and intraocular lens (IOL) implantation. Early postoperative mechanical wrapping of the anterior and posterior capsules plays a significant role in preventing IOL decentration and tilt, as well as formation of the IOL-capsular complex which reduces the incidence of posterior cataract opacity. Although up to 2-3 degree tilt and a 0.2-0.3 mm decentration are common and clinically unnoticed for any design of IOL, larger extent of tilt and decentration has a negative impact on the optical performance. IOL decentration ≥ 0.4 mm or/and IOL tilt ≥7degree were considered clinically significant cause of poor post-surgery visual quality especially for optical sophisticated IOLs. This negative impact does not affect various types of IOLs equally. Several studies indicated that AL was an independent risk factor of IOL decentration and tilt for emmetropic or moderate myopic eyes. However, there is scarce evidence on characteristics and factors associated with clinically significant IOL decentration and tilt in highly myopic eyes. For patients with high myopia, they often have a longer axial length and a larger capsule diameter, which reduces the rotational stability of the IOL and may lead to tilt, decentration and displacement of IOL. Currently, there is no literature guidance to compare the results of cataract surgery combined various types of IOLs implantation in patients with high myopia. The novel anterior segment optical coherence tomography (AS-OCT) device, CASIA2 can evaluate the IOL capsule bending and the lens position after cataract surgery. Also, CASIA2 can be used to documented the dynamic changes of IOL-capsular complex after surgery.

Conditions

Interventions

TypeNameDescription
PROCEDUREone-piecePatients underwent phacoemulsification cataract surgery with one-piece IOL implantation.
PROCEDUREplate-hapticPatients underwent phacoemulsification cataract surgery with plate-haptic IOL implantation.

Timeline

Start date
2022-01-07
Primary completion
2022-08-01
Completion
2022-12-01
First posted
2022-02-25
Last updated
2022-02-25

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT05255796. Inclusion in this directory is not an endorsement.