Cataract Surgery Technique and Ocular Clarity

NCT ID: NCT05489198

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2023-09-30

Brief Summary

The goal of this study is to study the restoration of quality of vision, expressed as straylight, in the immediate period after cataract surgery with two different phacoemulsification technologies.

Detailed Description

Cataract is an opacification of the lens. With cataract surgery, the lens is surgically removed after which a clear artificial intraocular lens is implanted. For patients, it is important that they regain functional vision as quickly as possible after surgery as a limited vision may increase the risk of falling and increases the dependency on other people. Surgical removal of the lens is done with a phacoemulsification system. Differences between phacoemulsification systems are the used pump type, the way the needle oscillates, and the fluid dynamics of the system. It is unknown whether any of the available systems offer an advantage on the amount of corneal oedema that develops after surgery and, therefore, results in a more rapid restoration of functional vision.

Conditions

Cataract

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Centurion

Cataract surgery performed with the Centurion phacoemulsification system

Group Type: EXPERIMENTAL

cataract surgery with Centurion phacoemulsification system

Intervention Type: PROCEDURE

Cataract surgery performed with the Centurion phacoemulsification system

Quatera 700

Cataract surgery performed with the Quatera 700 phacoemulsification system

Group Type: EXPERIMENTAL

cataract surgery with Quatera 700 phacoemulsification system

Intervention Type: PROCEDURE

Cataract surgery performed with the Quatera 700 phacoemulsification system

Interventions

cataract surgery with Centurion phacoemulsification system

Cataract surgery performed with the Centurion phacoemulsification system

Intervention Type: PROCEDURE

cataract surgery with Quatera 700 phacoemulsification system

Cataract surgery performed with the Quatera 700 phacoemulsification system

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of cataract in both eyes,
• Having consented to and is planned to undergo cataract surgery in both eyes,
• Planned for implantation of a non-toric monofocal intraocular lens (IOL) in both eyes,
• A targeted refractive error of emmetropia,
• Corneal astigmatism of ≤1.5 D,
• Age of at least 18 years,
• Willing and able to participate in both preoperative and postoperative examinations, and
• Agreeing to sign the informed consent form.

Exclusion Criteria

• Insufficient understanding of the Dutch language to comply with study procedures,
• Any comorbidity (other than cataract) that may significantly affect visual function and/or increase straylight and/or prolong visual recovery after surgery, such as significant macular degeneration, significant glaucoma, significant diabetic eye disease, significant ocular surface disease, cornea dystrophy, corneal opacification, significant vitreous opacities (such as asteroid hyalosis and clinically significant floaters), and history of cerebral vascular accident,
• Subjects with a history of ocular surgery (e.g., corneal refractive surgery),
• Subjects with an increased risk of complicated cataract surgery:
• Lens subluxation or (phaco)iridodonesis,
• Cataract brunescens, cataract rubra, cataract nigrans, or posterior polar cataract, and
• History of ocular trauma,
• Unability to be (reliably) measured with the C-Quant straylight meter or Pentacam corneal topographer, and
• A calculated IOL power in any eye that prohibits implantation of the same type of IOL in both eyes.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Amphia Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nic J. Reus, MD, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nic J. Reus, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Amphia Hospital

Central Contacts

Nic J. Reus, MD, PhD

Role: CONTACT

nreus@amphia.nl

+31765952239

Other Identifiers

1900

Identifier Type: -

Identifier Source: org_study_id