Cataract Surgery Technique and Ocular Clarity

Amphia Hospital

Status: Not yet enrolling

Conditions: Cataract

Treatments: Procedure: cataract surgery with Centurion phacoemulsification system; Procedure: cataract surgery with Quatera 700 phacoemulsification system

Study type: Interventional

Funder types: Other

Identifiers

NCT05489198

1900

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Centurion

Experimental group

Description:

Cataract surgery performed with the Centurion phacoemulsification system

Treatment:

Procedure: cataract surgery with Centurion phacoemulsification system

Quatera 700

Experimental group

Description:

Cataract surgery performed with the Quatera 700 phacoemulsification system

Treatment:

Procedure: cataract surgery with Quatera 700 phacoemulsification system