Clinical Outcome of Extended-depth-of-focus Trifocal Intraocualr Lens (Triumf) Implantation

Not Applicable

Completed

• Conditions: Presbyopia
• Interventions: Device: Triumf

• Registration Number: NCT04392024
• Lead Sponsor: Samsung Medical Center

Brief Summary

Clinical outcome of extended-depth-of-focus trifocal intraocualr lens (Triumf) implantation

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-29
• Study First Submitted: 2020-05-15
• Study First Submitted QC: 2020-05-15
• Study First Posted: 2020-05-18
• Primary Completion: 2022-01-22
• Study Completion: 2022-01-26
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. Adult at the age of 21 or older at the time of the pre-operative examination and willing to have surgery on their 2nd eye within 7-28 days of their 1st eye
2. Age-related cataract
3. A patient with preoperative corneal astigmatism from IOL Master less than 1 diopters
4. A patient want presbyopia correction at the same time as cataract surgery
5. A patient has the visual potential of 20/25 or better in each eye after cataract removal and IOL implantation
6. Written informed consent to surgery and participation in the study

Exclusion Criteria

1. Those with other diseases that can affect capsule stability such as pseudoexoliation syndrome, glaucoma, traumatic cataract
2. Pregnant woman and lactating woman
3. A patient with history of ocular trauma or ocular surgery (Intraocular surgery, refractive surgery, ocular surface surgery) in either eye
4. A patient with evidence of keratoconus or significant irregular astigmatism on pre-operative topography in either eye
5. If expectations for presbyopia correction are too high
6. Those who are not able to read and understand the informed consent (illiterate or foreigners)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Triumf	Triumf	Subjects who have cataract surgery with Triumf IOL

Primary Outcome Measures

Name	Time	Method
Uncorrected distant visual acuity	3 months	Visual acuity at distant with bare eyes
Uncorrected near visual acuity	3 months	Visual acuity at near with bare eyes

Secondary Outcome Measures

Name	Time	Method
Contrast sensitivity	3 months	Ability to recognize figure or letter at different contrast environment
Quality of Vision	3 months	Degree of various symptoms associated with vision

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of