Cataract Surgery Technique and Ocular Clarity
- Conditions
- Cataract
- Interventions
- Procedure: cataract surgery with Centurion phacoemulsification systemProcedure: cataract surgery with Quatera 700 phacoemulsification system
- Registration Number
- NCT05489198
- Lead Sponsor
- Amphia Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 15
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Centurion cataract surgery with Centurion phacoemulsification system Cataract surgery performed with the Centurion phacoemulsification system Quatera 700 cataract surgery with Quatera 700 phacoemulsification system Cataract surgery performed with the Quatera 700 phacoemulsification system
- Primary Outcome Measures
Name Time Method Straylight 1 month after surgery Amount of straylight measured with C-Quant, expressed as log(s)
- Secondary Outcome Measures
Name Time Method Total surgery time Surgery day Total surgery time per eye
Corneal densitometry 1 month after surgery Corneal densitometry measured with Pentacam, expressed as percentage
Corneal pachymetry 1 week after surgery Corneal thickness measured with Pentacam, expressed as um
Patient-Perceived Satisfactory Improvement in Vision 1 month after surgery Degree of satisfactory improvement in vision (possible answers are: a) worse, b) unchanged, c) unsatisfactory improved, d) satisfactory improved, e) good to very good improved)
Amount of phaco energy used Surgery day Amount of phaco energy used, expressed as Cumulative Dissipated Energy (CDE, for Alcon Centurion) or as Equivalent Phaco Time (EPT, for Zeiss Quatera 700)
Amount of balanced salt solution used Surgery day Amount of balanced salt solution used, expressed in milliliters
Presence of corneal oedema 1 month after surgery Presence of corneal oedema with slit lamp biomicroscopy
Catquest-9SF 1 month after surgery Catquest-9-Short-Form patient-reported outcome measure, expressed as Rasch score (min: -6.14, max: +5.71, lower scores mean a better result) and sum score (min: 9, max: 36, lower scores mean a better result)
Uncorrected Distance Visual Acuity 1 month after surgery Uncorrected Distance Visual Acuity, expressed as logMAR
Corrected Distance Visual Acuity 1 week after surgery Corrected Distance Visual Acuity, expressed as logMAR