Cataract
Conditions
Keywords
Straylight, Phacoemulsification, Cataract
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.
Interventions
PROCEDUREcataract surgery with Centurion phacoemulsification system
Cataract surgery performed with the Centurion phacoemulsification system
PROCEDUREcataract surgery with Quatera 700 phacoemulsification system
Cataract surgery performed with the Quatera 700 phacoemulsification system
Sponsors
Amphia Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, comparative, single-arm, randomised, and single-centre study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Straylight | preoperative | Amount of straylight measured with C-Quant, expressed as log(s) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of corneal oedema | preoperative | Presence of corneal oedema with slit lamp biomicroscopy |
| Corneal densitometry | preoperative | Corneal densitometry measured with Pentacam, expressed as percentage |
| 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 |
| Corneal pachymetry | 1 month after surgery | Corneal thickness measured with Pentacam, expressed as um |
| Uncorrected Distance Visual Acuity | preoperative | Uncorrected Distance Visual Acuity, expressed as logMAR |
| Corrected Distance Visual Acuity | preoperative | Corrected Distance Visual Acuity, expressed as logMAR |
| Catquest-9SF | preoperative | 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) |
| Patient-Perceived Satisfactory Improvement in Vision | 1-2 hours 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) |
| Total surgery time | Surgery day | Total surgery time per eye |
Contacts
Primary ContactNic J. Reus, MD, PhD
Outcome results
None listed