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

Age-related Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05255796
• Other study ID #: 20211213CTR
• Status: Recruiting
• Phase: N/A
• Start date: January 7, 2022
• Est. completion date: December 2022

Study information

• Verified date: February 2022
• Source: Wenzhou Medical University
• Contact: Pingjun Chang
• Phone: 18868410303
• Email: 364669877[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2022
• Est. primary completion date: August 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• The patients are diagnosed age related cataract or complicated cataract with axial length over 26mm

• The patients' age over 18 years old

• The patients plan to receive cataract surgery in Eye hospital of Wenzhou Medical University

• The dialated pupils are over 6mm

• Patients are willing and able to complete the follow-ups

Exclusion Criteria:

• Patients with other types of cataract

• Patients have complications in the surgery and after surgery

• Patients have other severe diseases of eyes

Related Conditions & MeSH terms

• Age-related Cataract
• Cataract
• Myopia

Intervention

Procedure:
• one-piece
Patients underwent phacoemulsification cataract surgery with one-piece IOL implantation.
• plate-haptic
Patients underwent phacoemulsification cataract surgery with plate-haptic IOL implantation.

Locations

Country	Name	City	State
China	Eye Hospital of Wenzhou Medical College	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The position of IOL	Evaluation of the position of IOL through tilt, decentration and the process of capsule bending using CASIA2.	The 1st day after surgery
Primary	The position of IOL	Evaluation of the position of IOL through tilt, decentration and the process of capsule bending using CASIA2.	The 1st week after surgery
Primary	The position of IOL	Evaluation of the position of IOL through tilt, decentration and the process of capsule bending using CASIA2.	The 1st month after surgery
Primary	The position of IOL	Evaluation of the position of IOL through tilt, decentration and the process of capsule bending using CASIA2.	The 3rd month after surgery