Cataract Surgery Technique and Ocular Clarity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Ocular Clarity After Cataract Surgery With Two Different Phacoemulsification Systems

Conditions
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Cataract

Intervention / Treatment
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* Procedure: cataract surgery with Centurion phacoemulsification system
* Procedure: cataract surgery with Quatera 700 phacoemulsification system


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, comparative, single-arm, randomised, and single-centre study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Centurion<br>Cataract surgery performed with the Centurion phacoemulsification system | Procedure: cataract surgery with Centurion phacoemulsification system<br>* Cataract surgery performed with the Centurion phacoemulsification system<br>|
| Experimental: Quatera 700<br>Cataract surgery performed with the Quatera 700 phacoemulsification system | Procedure: cataract surgery with Quatera 700 phacoemulsification system<br>* Cataract surgery performed with the Quatera 700 phacoemulsification system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Straylight | Amount of straylight measured with C-Quant, expressed as log(s) | preoperative | 
| Straylight | Amount of straylight measured with C-Quant, expressed as log(s) | 1-2 hours after surgery | 
| Straylight | Amount of straylight measured with C-Quant, expressed as log(s) | 1 day after surgery | 
| Straylight | Amount of straylight measured with C-Quant, expressed as log(s) | 1 week after surgery | 
| Straylight | Amount of straylight measured with C-Quant, expressed as log(s) | 1 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal densitometry | Corneal densitometry measured with Pentacam, expressed as percentage | preoperative | 
| Corneal densitometry | Corneal densitometry measured with Pentacam, expressed as percentage | 1-2 hours after surgery | 
| Corneal densitometry | Corneal densitometry measured with Pentacam, expressed as percentage | 1 day after surgery | 
| Corneal densitometry | Corneal densitometry measured with Pentacam, expressed as percentage | 1 week after surgery | 
| Corneal densitometry | Corneal densitometry measured with Pentacam, expressed as percentage | 1 month after surgery | 
| Amount of phaco energy used | Amount of phaco energy used, expressed as Cumulative Dissipated Energy (CDE, for Alcon Centurion) or as Equivalent Phaco Time (EPT, for Zeiss Quatera 700) | Surgery day | 
| Amount of balanced salt solution used | Amount of balanced salt solution used, expressed in milliliters | Surgery day | 
| Total surgery time | Total surgery time per eye | Surgery day | 
| Uncorrected Distance Visual Acuity | Uncorrected Distance Visual Acuity, expressed as logMAR | preoperative | 
| Uncorrected Distance Visual Acuity | Uncorrected Distance Visual Acuity, expressed as logMAR | 1-2 hours after surgery | 
| Uncorrected Distance Visual Acuity | Uncorrected Distance Visual Acuity, expressed as logMAR | 1 day after surgery | 
| Uncorrected Distance Visual Acuity | Uncorrected Distance Visual Acuity, expressed as logMAR | 1 week after surgery | 
| Uncorrected Distance Visual Acuity | Uncorrected Distance Visual Acuity, expressed as logMAR | 1 month after surgery | 
| Corrected Distance Visual Acuity | Corrected Distance Visual Acuity, expressed as logMAR | preoperative | 
| Corrected Distance Visual Acuity | Corrected Distance Visual Acuity, expressed as logMAR | 1 day after surgery | 
| Corrected Distance Visual Acuity | Corrected Distance Visual Acuity, expressed as logMAR | 1 week after surgery | 
| Corneal pachymetry | Corneal thickness measured with Pentacam, expressed as um | 1 month after surgery | 
| Corneal pachymetry | Corneal thickness measured with Pentacam, expressed as um | preoperative | 
| Corneal pachymetry | Corneal thickness measured with Pentacam, expressed as um | 1-2 hours after surgery | 
| Corneal pachymetry | Corneal thickness measured with Pentacam, expressed as um | 1 day after surgery | 
| Corneal pachymetry | Corneal thickness measured with Pentacam, expressed as um | 1 week after surgery | 
| Presence of corneal oedema | Presence of corneal oedema with slit lamp biomicroscopy | preoperative | 
| Presence of corneal oedema | Presence of corneal oedema with slit lamp biomicroscopy | 1-2 hours after surgery | 
| Presence of corneal oedema | Presence of corneal oedema with slit lamp biomicroscopy | 1 day after surgery | 
| Presence of corneal oedema | Presence of corneal oedema with slit lamp biomicroscopy | 1 week after surgery | 
| Presence of corneal oedema | Presence of corneal oedema with slit lamp biomicroscopy | 1 month after surgery | 
| Catquest-9SF | 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) | preoperative | 
| Catquest-9SF | 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) | 1-2 hours after surgery | 
| Catquest-9SF | 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) | 1 day after surgery | 
| Catquest-9SF | 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) | 1 week after surgery | 
| Catquest-9SF | 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) | 1 month after surgery | 
| Patient-Perceived Satisfactory Improvement in Vision | 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) | 1-2 hours after surgery | 
| Patient-Perceived Satisfactory Improvement in Vision | 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) | 1 day after surgery | 
| Patient-Perceived Satisfactory Improvement in Vision | 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) | 1 week after surgery | 
| Patient-Perceived Satisfactory Improvement in Vision | 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) | 1 month after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Straylight, Phacoemulsification, Cataract