Cataract Surgery Technique and Ocular Clarity
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Centurion Cataract surgery performed with the Centurion phacoemulsification system |
Procedure: cataract surgery with Centurion phacoemulsification system
Cataract surgery performed with the Centurion phacoemulsification system
|
| Experimental: Quatera 700 Cataract surgery performed with the Quatera 700 phacoemulsification system |
Procedure: cataract surgery with Quatera 700 phacoemulsification system
Cataract surgery performed with the Quatera 700 phacoemulsification system
|
Outcome Measures
Primary Outcome Measures
- Straylight [preoperative]
Amount of straylight measured with C-Quant, expressed as log(s)
- Straylight [1-2 hours after surgery]
Amount of straylight measured with C-Quant, expressed as log(s)
- Straylight [1 day after surgery]
Amount of straylight measured with C-Quant, expressed as log(s)
- Straylight [1 week after surgery]
Amount of straylight measured with C-Quant, expressed as log(s)
- Straylight [1 month after surgery]
Amount of straylight measured with C-Quant, expressed as log(s)
Secondary Outcome Measures
- Corneal densitometry [preoperative]
Corneal densitometry measured with Pentacam, expressed as percentage
- Corneal densitometry [1-2 hours after surgery]
Corneal densitometry measured with Pentacam, expressed as percentage
- Corneal densitometry [1 day after surgery]
Corneal densitometry measured with Pentacam, expressed as percentage
- Corneal densitometry [1 week after surgery]
Corneal densitometry measured with Pentacam, expressed as percentage
- Corneal densitometry [1 month after surgery]
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
- Total surgery time [Surgery day]
Total surgery time per eye
- Uncorrected Distance Visual Acuity [preoperative]
Uncorrected Distance Visual Acuity, expressed as logMAR
- Uncorrected Distance Visual Acuity [1-2 hours after surgery]
Uncorrected Distance Visual Acuity, expressed as logMAR
- Uncorrected Distance Visual Acuity [1 day after surgery]
Uncorrected Distance Visual Acuity, expressed as logMAR
- Uncorrected Distance Visual Acuity [1 week after surgery]
Uncorrected Distance Visual Acuity, expressed as logMAR
- Uncorrected Distance Visual Acuity [1 month after surgery]
Uncorrected Distance Visual Acuity, expressed as logMAR
- Corrected Distance Visual Acuity [preoperative]
Corrected Distance Visual Acuity, expressed as logMAR
- Corrected Distance Visual Acuity [1 day after surgery]
Corrected Distance Visual Acuity, expressed as logMAR
- Corrected Distance Visual Acuity [1 week after surgery]
Corrected Distance Visual Acuity, expressed as logMAR
- Corneal pachymetry [1 month after surgery]
Corneal thickness measured with Pentacam, expressed as um
- Corneal pachymetry [preoperative]
Corneal thickness measured with Pentacam, expressed as um
- Corneal pachymetry [1-2 hours after surgery]
Corneal thickness measured with Pentacam, expressed as um
- Corneal pachymetry [1 day after surgery]
Corneal thickness measured with Pentacam, expressed as um
- Corneal pachymetry [1 week after surgery]
Corneal thickness measured with Pentacam, expressed as um
- Presence of corneal oedema [preoperative]
Presence of corneal oedema with slit lamp biomicroscopy
- Presence of corneal oedema [1-2 hours after surgery]
Presence of corneal oedema with slit lamp biomicroscopy
- Presence of corneal oedema [1 day after surgery]
Presence of corneal oedema with slit lamp biomicroscopy
- Presence of corneal oedema [1 week after surgery]
Presence of corneal oedema with slit lamp biomicroscopy
- Presence of corneal oedema [1 month after surgery]
Presence of corneal oedema with slit lamp biomicroscopy
- 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)
- Catquest-9SF [1-2 hours 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)
- Catquest-9SF [1 day 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)
- Catquest-9SF [1 week 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)
- 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)
- 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)
- Patient-Perceived Satisfactory Improvement in Vision [1 day 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)
- Patient-Perceived Satisfactory Improvement in Vision [1 week 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)
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosis of cataract in both eyes,
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Having consented to and is planned to undergo cataract surgery in both eyes,
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Planned for implantation of a non-toric monofocal intraocular lens (IOL) in both eyes,
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A targeted refractive error of emmetropia,
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Corneal astigmatism of ≤1.5 D,
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Age of at least 18 years,
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Willing and able to participate in both preoperative and postoperative examinations, and
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Agreeing to sign the informed consent form.
Exclusion Criteria:
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Insufficient understanding of the Dutch language to comply with study procedures,
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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,
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Subjects with a history of ocular surgery (e.g., corneal refractive surgery),
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Subjects with an increased risk of complicated cataract surgery:
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Lens subluxation or (phaco)iridodonesis,
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Cataract brunescens, cataract rubra, cataract nigrans, or posterior polar cataract, and
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History of ocular trauma,
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Unability to be (reliably) measured with the C-Quant straylight meter or Pentacam corneal topographer, and
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A calculated IOL power in any eye that prohibits implantation of the same type of IOL in both eyes.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Amphia Hospital
Investigators
- Principal Investigator: Nic J. Reus, MD, PhD, Amphia Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1900