Clinical trial NCT05489198: Cataract Surgery Technique and Ocular Clarity
Official title: Ocular Clarity After Cataract Surgery With Two Different Phacoemulsification Systems
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cataract
Keywords: Straylight
Phacoemulsification
Cataract
Lead sponsor: Amphia Hospital
Sponsor class: OTHER
First posted: 2022-08-05
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, comparative, single-arm, randomised, and single-centre study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Straylight
timeFrame: preoperative
measure: Straylight
timeFrame: 1-2 hours after surgery
measure: Straylight
timeFrame: 1 day after surgery
measure: Straylight
timeFrame: 1 week after surgery
measure: Straylight
timeFrame: 1 month after surgery
Secondary outcomes:
measure: Corneal densitometry
timeFrame: preoperative
measure: Corneal densitometry
timeFrame: 1-2 hours after surgery
measure: Corneal densitometry
timeFrame: 1 day after surgery
measure: Corneal densitometry
timeFrame: 1 week after surgery
measure: Corneal densitometry
timeFrame: 1 month after surgery
measure: Amount of phaco energy used
timeFrame: Surgery day
measure: Amount of balanced salt solution used
timeFrame: Surgery day
measure: Total surgery time
timeFrame: Surgery day
measure: Uncorrected Distance Visual Acuity
timeFrame: preoperative
measure: Uncorrected Distance Visual Acuity
timeFrame: 1-2 hours after surgery
measure: Uncorrected Distance Visual Acuity
timeFrame: 1 day after surgery
measure: Uncorrected Distance Visual Acuity
timeFrame: 1 week after surgery
measure: Uncorrected Distance Visual Acuity
timeFrame: 1 month after surgery
measure: Corrected Distance Visual Acuity
timeFrame: preoperative
measure: Corrected Distance Visual Acuity
timeFrame: 1 day after surgery
measure: Corrected Distance Visual Acuity
timeFrame: 1 week after surgery
measure: Corneal pachymetry
timeFrame: 1 month after surgery
measure: Corneal pachymetry
timeFrame: preoperative
measure: Corneal pachymetry
timeFrame: 1-2 hours after surgery
measure: Corneal pachymetry
timeFrame: 1 day after surgery
measure: Corneal pachymetry
timeFrame: 1 week after surgery
measure: Presence of corneal oedema
timeFrame: preoperative
measure: Presence of corneal oedema
timeFrame: 1-2 hours after surgery
measure: Presence of corneal oedema
timeFrame: 1 day after surgery
measure: Presence of corneal oedema
timeFrame: 1 week after surgery
measure: Presence of corneal oedema
timeFrame: 1 month after surgery
measure: Catquest-9SF
timeFrame: preoperative
measure: Catquest-9SF
timeFrame: 1-2 hours after surgery
measure: Catquest-9SF
timeFrame: 1 day after surgery
measure: Catquest-9SF
timeFrame: 1 week after surgery
measure: Catquest-9SF
timeFrame: 1 month after surgery
measure: Patient-Perceived Satisfactory Improvement in Vision
timeFrame: 1-2 hours after surgery
measure: Patient-Perceived Satisfactory Improvement in Vision
timeFrame: 1 day after surgery
measure: Patient-Perceived Satisfactory Improvement in Vision
timeFrame: 1 week after surgery
measure: Patient-Perceived Satisfactory Improvement in Vision
timeFrame: 1 month after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Amphia Hospital
name: Nic J. Reus, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: