Cataract Surgery Technique and Ocular Clarity

NCT05489198 | Unknown DMC

• 1 other identifier: 1900
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract

Keywords

Straylight; Phacoemulsification; Cataract

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (35)

• Corneal densitometry

  preoperative

• Corneal densitometry

  1-2 hours after surgery

• Corneal densitometry

  1 day after surgery

• Corneal densitometry

  1 week after surgery

• Corneal densitometry

  1 month after surgery

Study Arms (2)

Centurion

EXPERIMENTAL

Cataract surgery performed with the Centurion phacoemulsification system

Procedure: cataract surgery with Centurion phacoemulsification system

Quatera 700

EXPERIMENTAL

Cataract surgery performed with the Quatera 700 phacoemulsification system

Procedure: cataract surgery with Quatera 700 phacoemulsification system

Interventions

cataract surgery with Centurion phacoemulsification system PROCEDURE

Cataract surgery performed with the Centurion phacoemulsification system

Centurion

cataract surgery with Quatera 700 phacoemulsification system PROCEDURE

Cataract surgery performed with the Quatera 700 phacoemulsification system

Quatera 700

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amphia Hospital: lead

MeSH Terms

Conditions

Cataract

Interventions

Cataract Extraction

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Nic J. Reus, MD, PhD

  Amphia Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nic J. Reus, MD, PhD

CONTACT

+31765952239; nreus@amphia.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, comparative, single-arm, randomised, and single-centre study

Study Record Dates

• First Submitted: July 29, 2022
• First Posted: August 5, 2022
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: August 5, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share