Cataract Surgery Technique and Ocular Clarity

Ocular Clarity After Cataract Surgery With Two Different Phacoemulsification Systems

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cataract
• Intervention / Treatment: Procedure: cataract surgery with Centurion phacoemulsification system; Procedure: cataract surgery with Quatera 700 phacoemulsification system

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 Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nic J. Reus, MD, PhD; Phone Number: +31765952239; Email: nreus@amphia.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Amphia Hospital
• Investigators: Principal Investigator: Nic J. Reus, MD, PhD, Amphia Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: July 29, 2022
• First Submitted That Met QC Criteria: August 3, 2022
• First Posted (Actual): August 5, 2022

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Cataract; Phacoemulsification; Straylight
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: 1900

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No