We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cataract Surgery Technique and Ocular Clarity

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05489198
Recruitment Status : Not yet recruiting
First Posted : August 5, 2022
Last Update Posted : August 5, 2022
Sponsor:
Information provided by (Responsible Party):
Nic J. Reus, MD, PhD, Amphia Hospital

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
Cataract Procedure: cataract surgery with Centurion phacoemulsification system Procedure: cataract surgery with Quatera 700 phacoemulsification system Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, comparative, single-arm, randomised, and single-centre study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ocular Clarity After Cataract Surgery With Two Different Phacoemulsification Systems
Estimated Study Start Date : September 2022
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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




Primary Outcome Measures :
  1. Straylight [ Time Frame: preoperative ]
    Amount of straylight measured with C-Quant, expressed as log(s)

  2. Straylight [ Time Frame: 1-2 hours after surgery ]
    Amount of straylight measured with C-Quant, expressed as log(s)

  3. Straylight [ Time Frame: 1 day after surgery ]
    Amount of straylight measured with C-Quant, expressed as log(s)

  4. Straylight [ Time Frame: 1 week after surgery ]
    Amount of straylight measured with C-Quant, expressed as log(s)

  5. Straylight [ Time Frame: 1 month after surgery ]
    Amount of straylight measured with C-Quant, expressed as log(s)


Secondary Outcome Measures :
  1. Corneal densitometry [ Time Frame: preoperative ]
    Corneal densitometry measured with Pentacam, expressed as percentage

  2. Corneal densitometry [ Time Frame: 1-2 hours after surgery ]
    Corneal densitometry measured with Pentacam, expressed as percentage

  3. Corneal densitometry [ Time Frame: 1 day after surgery ]
    Corneal densitometry measured with Pentacam, expressed as percentage

  4. Corneal densitometry [ Time Frame: 1 week after surgery ]
    Corneal densitometry measured with Pentacam, expressed as percentage

  5. Corneal densitometry [ Time Frame: 1 month after surgery ]
    Corneal densitometry measured with Pentacam, expressed as percentage

  6. Amount of phaco energy used [ Time Frame: 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)

  7. Amount of balanced salt solution used [ Time Frame: Surgery day ]
    Amount of balanced salt solution used, expressed in milliliters

  8. Total surgery time [ Time Frame: Surgery day ]
    Total surgery time per eye

  9. Uncorrected Distance Visual Acuity [ Time Frame: preoperative ]
    Uncorrected Distance Visual Acuity, expressed as logMAR

  10. Uncorrected Distance Visual Acuity [ Time Frame: 1-2 hours after surgery ]
    Uncorrected Distance Visual Acuity, expressed as logMAR

  11. Uncorrected Distance Visual Acuity [ Time Frame: 1 day after surgery ]
    Uncorrected Distance Visual Acuity, expressed as logMAR

  12. Uncorrected Distance Visual Acuity [ Time Frame: 1 week after surgery ]
    Uncorrected Distance Visual Acuity, expressed as logMAR

  13. Uncorrected Distance Visual Acuity [ Time Frame: 1 month after surgery ]
    Uncorrected Distance Visual Acuity, expressed as logMAR

  14. Corrected Distance Visual Acuity [ Time Frame: preoperative ]
    Corrected Distance Visual Acuity, expressed as logMAR

  15. Corrected Distance Visual Acuity [ Time Frame: 1 day after surgery ]
    Corrected Distance Visual Acuity, expressed as logMAR

  16. Corrected Distance Visual Acuity [ Time Frame: 1 week after surgery ]
    Corrected Distance Visual Acuity, expressed as logMAR

  17. Corneal pachymetry [ Time Frame: 1 month after surgery ]
    Corneal thickness measured with Pentacam, expressed as um

  18. Corneal pachymetry [ Time Frame: preoperative ]
    Corneal thickness measured with Pentacam, expressed as um

  19. Corneal pachymetry [ Time Frame: 1-2 hours after surgery ]
    Corneal thickness measured with Pentacam, expressed as um

  20. Corneal pachymetry [ Time Frame: 1 day after surgery ]
    Corneal thickness measured with Pentacam, expressed as um

  21. Corneal pachymetry [ Time Frame: 1 week after surgery ]
    Corneal thickness measured with Pentacam, expressed as um

  22. Presence of corneal oedema [ Time Frame: preoperative ]
    Presence of corneal oedema with slit lamp biomicroscopy

  23. Presence of corneal oedema [ Time Frame: 1-2 hours after surgery ]
    Presence of corneal oedema with slit lamp biomicroscopy

  24. Presence of corneal oedema [ Time Frame: 1 day after surgery ]
    Presence of corneal oedema with slit lamp biomicroscopy

  25. Presence of corneal oedema [ Time Frame: 1 week after surgery ]
    Presence of corneal oedema with slit lamp biomicroscopy

  26. Presence of corneal oedema [ Time Frame: 1 month after surgery ]
    Presence of corneal oedema with slit lamp biomicroscopy

  27. Catquest-9SF [ Time Frame: 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)

  28. Catquest-9SF [ Time Frame: 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)

  29. Catquest-9SF [ Time Frame: 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)

  30. Catquest-9SF [ Time Frame: 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)

  31. Catquest-9SF [ Time Frame: 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)

  32. Patient-Perceived Satisfactory Improvement in Vision [ Time Frame: 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)

  33. Patient-Perceived Satisfactory Improvement in Vision [ Time Frame: 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)

  34. Patient-Perceived Satisfactory Improvement in Vision [ Time Frame: 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)

  35. Patient-Perceived Satisfactory Improvement in Vision [ Time Frame: 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05489198


Contacts
Layout table for location contacts
Contact: Nic J. Reus, MD, PhD +31765952239 nreus@amphia.nl

Sponsors and Collaborators
Amphia Hospital
Investigators
Layout table for investigator information
Principal Investigator: Nic J. Reus, MD, PhD Amphia Hospital
Layout table for additonal information
Responsible Party: Nic J. Reus, MD, PhD, Principal Investigator, Amphia Hospital
ClinicalTrials.gov Identifier: NCT05489198    
Other Study ID Numbers: 1900
First Posted: August 5, 2022    Key Record Dates
Last Update Posted: August 5, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nic J. Reus, MD, PhD, Amphia Hospital:
Straylight
Phacoemulsification
Cataract
Additional relevant MeSH terms:
Layout table for MeSH terms
Cataract
Lens Diseases
Eye Diseases