Influence of Different Tamponade Eyes on IOL-capsular Complex
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2022
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2022
CompletedFirst Posted
Study publicly available on registry
March 25, 2022
CompletedStudy Start
First participant enrolled
April 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMarch 25, 2022
March 1, 2022
7 months
March 16, 2022
March 16, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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 1st day after surgery
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 1st week after surgery
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 1st month after surgery
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 3rd month after surgery
Study Arms (4)
phacovitrectomy surgery with silicone oil tamponade
EXPERIMENTALpatients who had phacovitrectomy surgery with silicone oil tamponade.The patients diagnosed cataract The patients' ages are over 50.
phacovitrectomy surgery with gas tamponade
EXPERIMENTALpatients who had phacovitrectomy surgery with gas tamponade.The patients diagnosed cataract The patients' ages are over 50.
phacovitrectomy surgery with balanced saline solution tamponade
EXPERIMENTALpatients who had phacovitrectomy surgery with balanced saline solution tamponade.The patients diagnosed cataract The patients' ages are over 50.
phacoemulsifacation surgery without vitrectomy
EXPERIMENTALpatients who had phacoemulsifacation surgery without vitrectomy.The patients diagnosed cataract The patients' ages are over 50.
Interventions
Patients in this study will receive phacovitrectomy surgery with silicone oil tamponade.
Patients in this study will receive phacovitrectomy surgery with gas tamponade
Patients in this study will receive phacovitrectomy surgery with balanced saline solution tamponade
Patients in this study will receive phacoemulsifacation surgery without vitrectomy.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Patients with other type of cataract
- Patients have severe complications in the surgery and after surgery
- Patients have other severe diseases of eyes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yune Zhao
Ophthalmology and Optometry Hospital
Central Study Contacts
Yune Zhao, MD
CONTACT
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice president of Eye Hospital of Wenzhou Medical University
Study Record Dates
First Submitted
March 16, 2022
First Posted
March 25, 2022
Study Start
April 1, 2022
Primary Completion
November 1, 2022
Study Completion
December 1, 2022
Last Updated
March 25, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share