Effective Lens Position After Cataract Surgery

• Sponsor: Wenzhou Medical University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04443101
• Collaborator: (none)
• Enrollment: 300
• Locations: 2
• Anticipated Duration (Months): 26.9
• Patients Per Site: 150
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief Summary

Cataract patients were implanted with different types of intraocular lenses for grouping. SSOCT scanning was used to measure ELP and optometry.

Condition or Disease	Intervention/Treatment	Phase
Age-related Cataract	Other: different types of intracular lens

Detailed Description

Cataract patients were implanted with different types of intraocular lenses for grouping. Perform SSOCT scan that was used to measure effective lens position and optometry at different postoperative follow-up time .

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Comparison of Changes in Effective Lens Position of Different Types of Intraocular Lens
• Actual Study Start Date: Jan 1, 2019
• Anticipated Primary Completion Date: Dec 30, 2020
• Anticipated Study Completion Date: Mar 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Group（SN6CWS） Group（SN6CWS）：Implant SN6CWS intraocular lens	Other: different types of intracular lens; different types of intracular lens
Group（MI60） Group（MI60）：Implant MI60 intraocular lens	Other: different types of intracular lens; different types of intracular lens
Group（Aspira-aA） Group（Aspira-aA）：Implant Aspira-aA intraocular lens	Other: different types of intracular lens; different types of intracular lens

Outcome Measures

Primary Outcome Measures

1. effective lens position [up to 3 months after cataract surgery]

   Changes of effective lens position at different time points after cataract surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• a.Diagnosed as cataract;

• b.Implanted intraocular lens: SN6CWS, Aspira-aA, MI60;

• c.Cataract phacoemulsification and intraocular lens implantation.

Exclusion Criteria:

• a.Combined with corneal opacity, glaucoma, uveitis, retinal detachment and other eye diseases;

• b.A history of intraocular surgery or trauma other than cataract surgery;

• c.Intraoperative complications such as tearing of the capsule and IOL failure to implant;

• d.Endophthalmitis, corneal endothelial decompensation and other postoperative complications;

• e.Those with incomplete data collected during the follow-up period of postoperative patients.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ophthalmology and Optometry Hospital	Wenzhou	Zhejiang	China	325027
2	Wenzhou Medical University	Wenzhou	Zhejiang	China	325027

Sponsors and Collaborators

• Wenzhou Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: yin ying zhao, Principal Investigator, Wenzhou Medical University
• ClinicalTrials.gov Identifier: NCT04443101
• Other Study ID Numbers: SSOCT-ELP
• First Posted: Jun 23, 2020
• Last Update Posted: Jun 23, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cataract

Study Results

No Results Posted as of Jun 23, 2020