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Influence of Different Tamponade Eyes on IOL-capsular Complex

Primary Purpose

Cataract, Vitreoretinal Abnormality

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
phacovitrectomy surgery with silicone oil tamponade
phacovitrectomy surgery with gas tamponade
phacovitrectomy surgery with balanced saline solution tamponade
phacoemulsifacation surgery without vitrectomy
Sponsored by
Wenzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Various Types of intravitreal tamponade materials

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The patients are diagnosed age related cataract or complicated cataract with or without vitreoretinal diseases
  • The patients' age over 50 years old
  • The patients plan to receive cataract surgery with or without vitrectomy in Eye hospital of Wenzhou Medical University
  • The dilated pupils are over 7mm
  • Patients are willing and able to complete the follow-ups.

Exclusion Criteria:

  • Patients with other type of cataract
  • Patients have severe complications in the surgery and after surgery
  • Patients have other severe diseases of eyes

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    phacovitrectomy surgery with silicone oil tamponade

    phacovitrectomy surgery with gas tamponade

    phacovitrectomy surgery with balanced saline solution tamponade

    phacoemulsifacation surgery without vitrectomy

    Arm Description

    patients who had phacovitrectomy surgery with silicone oil tamponade.The patients diagnosed cataract The patients' ages are over 50.

    patients who had phacovitrectomy surgery with gas tamponade.The patients diagnosed cataract The patients' ages are over 50.

    patients who had phacovitrectomy surgery with balanced saline solution tamponade.The patients diagnosed cataract The patients' ages are over 50.

    patients who had phacoemulsifacation surgery without vitrectomy.The patients diagnosed cataract The patients' ages are over 50.

    Outcomes

    Primary Outcome Measures

    The position of IOL
    Evaluation of the position of IOL through tilt, decentration,rotation and the process of capsule bending using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device)
    The position of IOL
    Evaluation of the position of IOL through tilt, decentration,rotation and the process of capsule bending using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device)
    The position of IOL
    Evaluation of the position of IOL through tilt, decentration,rotation and the process of capsule bending using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device)
    The position of IOL
    Evaluation of the position of IOL through tilt, decentration,rotation and the process of capsule bending using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device)

    Secondary Outcome Measures

    Full Information

    First Posted
    March 16, 2022
    Last Updated
    March 16, 2022
    Sponsor
    Wenzhou Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05296486
    Brief Title
    Influence of Different Tamponade Eyes on IOL-capsular Complex
    Official Title
    Influence of Different Tamponade Eyes on IOL-capsular Complex After Cataract Surgery Combined With Vitrectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    April 1, 2022 (Anticipated)
    Primary Completion Date
    November 1, 2022 (Anticipated)
    Study Completion Date
    December 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Wenzhou Medical University

    4. Oversight

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

    5. Study Description

    Brief Summary
    Cataract and vitreoretinal diseases often occur simultaneously or cataract is a predictable consequence of vitreoretinal surgery.A combined surgery called phacovitrectomy, has been proved to be comparably safe and effective compared with vitrectomy alone. For fundus surgeons, silicone oil(SO),gas and balanced saline solution are frequently-used intravitreal tamponade mediums for retinal repair after vitrectomy. There are many factors that may affect how the lens changes position after the operation including the different intravitreal tamponade materials and different IOL types. This study was designed to evaluate the differences of IOL position and capsule bending between Silicone oil filled eyes,gas filled eyes, balanced saline solution filled eyes and normal eyes. The IOL-capsular complex is formed after cataract surgery and intraocular lens (IOL) implantation. Early postoperative mechanical wrapping of the anterior and posterior capsules plays a significant role in preventing IOL decentration and tilt, as well as formation of the IOL-capsular complex which reduces the incidence of posterior cataract opacity. Although up to 2-3 degree tilt and a 0.2-0.3 mm decentration are common and clinically unnoticed, larger extent of tilt and decentration has a negative impact on the optical performance. IOL decentration ≥ 0.4 mm or/and IOL tilt ≥7degree were considered clinically significant because of poor post-surgery visual quality. Currently, there is no literature guidance to compare the results of phacovitrectomy combined various types of intravitreal tamponade materials in patients using CASIA2. The novel anterior segment optical coherence tomography (AS-OCT) device, CASIA2 can evaluate the IOL capsule bending and the lens position after cataract surgery. Also, CASIA2 can be used to documented the dynamic changes of IOL-capsular complex after surgery.
    Detailed Description
    Cataract and vitreoretinal diseases often occur simultaneously or cataract is a predictable consequence of vitreoretinal surgery. Although the optimal treatment for patients with both vitreoretinal and cataract disease is still a matter of debate, a combined surgery called phacovitrectomy, has been proved to be comparably safe and effective compared with vitrectomy alone. For fundus surgeons, silicone oil(SO),gas and balanced saline solution are frequently-used intravitreal tamponade mediums for retinal repair after vitrectomy. As a biochemically inert polymer, SO is widely used in vitreoretinal surgery and was considered to be well-tolerated and not threatening to retinal physiology. The gases in therapeutic use ([SF6], [C2F6], or [C3F8]) may be mixed with air in vitrectomy or used as 100% gas in pneumatic retinopexy. There are many factors that may affect how the lens changes position after the operation including the different intravitreal tamponade materials and different IOL types. This study was designed to evaluate the differences of IOL position and capsule bending between Silicone oil filled eyes,gas filled eyes, balanced saline solution filled eyes and normal eyes. The IOL-capsular complex is formed after cataract surgery and intraocular lens (IOL) implantation. Early postoperative mechanical wrapping of the anterior and posterior capsules plays a significant role in preventing IOL decentration and tilt, as well as formation of the IOL-capsular complex which reduces the incidence of posterior cataract opacity. Although up to 2-3 degree tilt and a 0.2-0.3 mm decentration are common and clinically unnoticed, larger extent of tilt and decentration has a negative impact on the optical performance. IOL decentration ≥ 0.4 mm or/and IOL tilt ≥7degree were considered clinically significant because of poor post-surgery visual quality. Currently, there is no literature guidance to compare the results of phacovitrectomy combined various types of intravitreal tamponade materials in patients using CASIA2. The novel anterior segment optical coherence tomography (AS-OCT) device, CASIA2 can evaluate the IOL capsule bending and the lens position after cataract surgery. Also, CASIA2 can be used to documented the dynamic changes of IOL-capsular complex after surgery.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cataract, Vitreoretinal Abnormality
    Keywords
    Various Types of intravitreal tamponade materials

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    phacovitrectomy surgery with silicone oil tamponade
    Arm Type
    Experimental
    Arm Description
    patients who had phacovitrectomy surgery with silicone oil tamponade.The patients diagnosed cataract The patients' ages are over 50.
    Arm Title
    phacovitrectomy surgery with gas tamponade
    Arm Type
    Experimental
    Arm Description
    patients who had phacovitrectomy surgery with gas tamponade.The patients diagnosed cataract The patients' ages are over 50.
    Arm Title
    phacovitrectomy surgery with balanced saline solution tamponade
    Arm Type
    Experimental
    Arm Description
    patients who had phacovitrectomy surgery with balanced saline solution tamponade.The patients diagnosed cataract The patients' ages are over 50.
    Arm Title
    phacoemulsifacation surgery without vitrectomy
    Arm Type
    Experimental
    Arm Description
    patients who had phacoemulsifacation surgery without vitrectomy.The patients diagnosed cataract The patients' ages are over 50.
    Intervention Type
    Procedure
    Intervention Name(s)
    phacovitrectomy surgery with silicone oil tamponade
    Intervention Description
    Patients in this study will receive phacovitrectomy surgery with silicone oil tamponade.
    Intervention Type
    Procedure
    Intervention Name(s)
    phacovitrectomy surgery with gas tamponade
    Intervention Description
    Patients in this study will receive phacovitrectomy surgery with gas tamponade
    Intervention Type
    Procedure
    Intervention Name(s)
    phacovitrectomy surgery with balanced saline solution tamponade
    Intervention Description
    Patients in this study will receive phacovitrectomy surgery with balanced saline solution tamponade
    Intervention Type
    Procedure
    Intervention Name(s)
    phacoemulsifacation surgery without vitrectomy
    Intervention Description
    Patients in this study will receive phacoemulsifacation surgery without vitrectomy.
    Primary Outcome Measure Information:
    Title
    The position of IOL
    Description
    Evaluation of the position of IOL through tilt, decentration,rotation and the process of capsule bending using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device)
    Time Frame
    The 1st day after surgery
    Title
    The position of IOL
    Description
    Evaluation of the position of IOL through tilt, decentration,rotation and the process of capsule bending using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device)
    Time Frame
    The 1st week after surgery
    Title
    The position of IOL
    Description
    Evaluation of the position of IOL through tilt, decentration,rotation and the process of capsule bending using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device)
    Time Frame
    The 1st month after surgery
    Title
    The position of IOL
    Description
    Evaluation of the position of IOL through tilt, decentration,rotation and the process of capsule bending using CAISA2(The novel anterior segment optical coherence tomography (AS-OCT) device)
    Time Frame
    The 3rd month after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: The patients are diagnosed age related cataract or complicated cataract with or without vitreoretinal diseases The patients' age over 50 years old The patients plan to receive cataract surgery with or without vitrectomy in Eye hospital of Wenzhou Medical University The dilated pupils are over 7mm Patients are willing and able to complete the follow-ups. Exclusion Criteria: Patients with other type of cataract Patients have severe complications in the surgery and after surgery Patients have other severe diseases of eyes
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Pingjun Chang
    Phone
    18868410303
    Email
    364669877@qq.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yune Zhao, MD
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yune Zhao
    Organizational Affiliation
    Ophthalmology and Optometry Hospital
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Influence of Different Tamponade Eyes on IOL-capsular Complex

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