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Rotational Stability of Different Intraocular Lenses in The Capsular Bag

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ClinicalTrials.gov Identifier: NCT03761745
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : April 26, 2019
Sponsor:
Information provided by (Responsible Party):
A-Yong Yu, Wenzhou Medical University

Brief Summary:
To evaluate the rotational stability difference among different intraocular lens. The rotational stability is evaluated by measurement of rotation of the IOL after surgery.

Condition or disease
Intraocular Lens Complication Phacoemulsification

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rotational Stability of Different Intraocular Lenses in The Capsular Bag
Actual Study Start Date : December 29, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : August 30, 2019



Primary Outcome Measures :
  1. Alignment of intraocular lens [ Time Frame: 1 day postoperatively ]
    The alignment of intraocular lens was evaluated by anterior segment photography

  2. Alignment of intraocular lens [ Time Frame: 1 week postoperatively ]
    The alignment of intraocular lens was evaluated by anterior segment photography

  3. Alignment of intraocular lens [ Time Frame: 1 month, postoperatively ]
    The alignment of intraocular lens was evaluated by anterior segment photography


Secondary Outcome Measures :
  1. Intraocular Pressure [ Time Frame: 1 day, 1 week, 1 month, postoperatively ]
    Intraocular Pressure measured by non-contact tonometers

  2. Corrected Visual Acuity (UCVA) at Distance [ Time Frame: 1 day, 1 week, 1 month, postoperatively ]
    UCVA was determined by subjective refraction

  3. Uncorrected Visual Acuity (UCVA) at Distance [ Time Frame: 1 day, 1 week, 1 month, postoperatively ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who received Femtosecond laser-assisted phacoemulsification surgery in The Eye Hospital of Wenzhou Medical University
Criteria

Inclusion Criteria:

  • Age ≥ 18 years
  • Patients who had received Femtosecond laser-assisted phacoemulsification surgery with IntelliAxis-L capsular mark.
  • The operation was smooth and there were no surgical complications.

Exclusion Criteria:

  • Corneal and other ocular diseases (such as corneal opacity, keratitis, glaucoma, uveitis, lens dislocation or subluxation, lens capsule relaxation, retinopathy, etc.);
  • History of ocular trauma or surgery before this cataract surgery;
  • intraoperative and postoperative complications, such as posterior capsule rupture, corneal endothelium decompensation;
  • Patients with severe or unstable heart, liver, kidney, lung, endocrine (including thyroid dysfunction), blood, mental dysfunction and other diseases affect the results of this study;

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): NCT03761745


Contacts
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Contact: AYong Yu, MD.PhD. +86-0577-88068880 yaybetter@hotmail.com
Contact: Xu Shao, MD 8613736995127 drxushao@126.com

Locations
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China, Zhejiang
Eye Hispital of Wenzhou Medical University Recruiting
Wenzhou, Zhejiang, China, 325000
Contact: AYong Yu, MD.PhD.         
Sponsors and Collaborators
Wenzhou Medical University
Investigators
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Principal Investigator: AYong Yu, MD.PhD. Wenzhou Medical University

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Responsible Party: A-Yong Yu, Rotational Stability of Different Intraocular Lenses in The Capsular Bag, Wenzhou Medical University
ClinicalTrials.gov Identifier: NCT03761745     History of Changes
Other Study ID Numbers: 2018Rotation
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: April 26, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by A-Yong Yu, Wenzhou Medical University:
Rotation
Postoperative Care