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

Sponsor
Wenzhou Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05255796
Collaborator
(none)
40
1
2
10.8
3.7

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: one-piece
  • Procedure: plate-haptic
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jan 7, 2022
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: one-piece

The patients' axial length is over 26 mm and are diagnosed age related cataract or complicated cataract.

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

Experimental: plate-haptic

The patients' axial length is over 26 mm and are diagnosed age related cataract or complicated cataract.

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

Outcome Measures

Primary Outcome Measures

  1. The position of IOL [The 1st day after surgery]

    Evaluation of the position of IOL through tilt, decentration and the process of capsule bending using CASIA2.

  2. The position of IOL [The 1st week after surgery]

    Evaluation of the position of IOL through tilt, decentration and the process of capsule bending using CASIA2.

  3. The position of IOL [The 1st month after surgery]

    Evaluation of the position of IOL through tilt, decentration and the process of capsule bending using CASIA2.

  4. The position of IOL [The 3rd month after surgery]

    Evaluation of the position of IOL through tilt, decentration and the process of capsule bending using CASIA2.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Eye Hospital of Wenzhou Medical College Hangzhou Zhejiang China 325027

Sponsors and Collaborators

  • Wenzhou Medical University

Investigators

  • Study Director: Yune Zhao, Ophthalmology and Optometry Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
ClinicalTrials.gov Identifier:
NCT05255796
Other Study ID Numbers:
  • 20211213CTR
First Posted:
Feb 25, 2022
Last Update Posted:
Feb 25, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Yune Zhao, Vice president of Eye Hospital of Wenzhou Medical University, Wenzhou Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 25, 2022