CataractNCT05296486
Influence of Different Tamponade Eyes on IOL-capsular Complex
A study testing phacovitrectomy surgery with silicone oil tamponade, phacovitrectomy surgery with gas tamponade and phacovitrectomy surgery with balanced saline solution tamponade in people with Cataract and Vitreoretinal Abnormality, run by Wenzhou Medical University.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Cataract, Vitreoretinal Abnormality
- What is being tested?
- phacovitrectomy surgery with silicone oil tamponade, phacovitrectomy surgery with gas tamponade and phacovitrectomy surgery with balanced saline solution tamponade
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 1 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients with other type of cataract
- Patients have severe complications in the surgery and after surgery
- Patients have other severe diseases of eyes
Trial locations and contacts
No sites are listed yet.
Yune Zhao, MD contact
About this study
Official title: Influence of Different Tamponade Eyes on IOL-capsular Complex After Cataract Surgery Combined With Vitrectomy
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.
Read more
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.
Read the 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.
- Conditions
- Cataract, Vitreoretinal Abnormality
- Being tested
- phacovitrectomy surgery with silicone oil tamponade, phacovitrectomy surgery with gas tamponade, phacovitrectomy surgery with balanced saline solution tamponade, phacoemulsifacation surgery without vitrectomy
- Keywords
- Various Types of intravitreal tamponade materials
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phacovitrectomy surgery with silicone oil tamponadeProcedure or surgery
Patients in this study will receive phacovitrectomy surgery with silicone oil tamponade.
phacovitrectomy surgery with gas tamponadeProcedure or surgery
Patients in this study will receive phacovitrectomy surgery with gas tamponade
phacovitrectomy surgery with balanced saline solution tamponadeProcedure or surgery
Patients in this study will receive phacovitrectomy surgery with balanced saline solution tamponade
phacoemulsifacation surgery without vitrectomyProcedure or surgery
Patients in this study will receive phacoemulsifacation surgery without vitrectomy.
| Study group | Role | What they receive |
|---|---|---|
| phacovitrectomy surgery with silicone oil tamponade | Experimental | patients who had phacovitrectomy surgery with silicone oil tamponade.The patients diagnosed cataract The patients' ages are over 50. Receives: Procedure: phacovitrectomy surgery with silicone oil tamponade |
| phacovitrectomy surgery with gas tamponade | Experimental | patients who had phacovitrectomy surgery with gas tamponade.The patients diagnosed cataract The patients' ages are over 50. Receives: Procedure: phacovitrectomy surgery with gas tamponade |
| phacovitrectomy surgery with balanced saline solution tamponade | Experimental | patients who had phacovitrectomy surgery with balanced saline solution tamponade.The patients diagnosed cataract The patients' ages are over 50. Receives: Procedure: phacovitrectomy surgery with balanced saline solution tamponade |
| phacoemulsifacation surgery without vitrectomy | Experimental | patients who had phacoemulsifacation surgery without vitrectomy.The patients diagnosed cataract The patients' ages are over 50. Receives: Procedure: phacoemulsifacation surgery without vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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）
Measured: 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）
Measured: 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）
Measured: 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）
Measured: The 3rd month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start1 Apr 2022 (estimated)
- Primary completion1 Nov 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yune Zhao, Wenzhou Medical University
- Investigators
- Yune Zhao, Study director, Ophthalmology and Optometry Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296486
- Sponsor's protocol ID
- IOL with different tamponade
- Status last verified
- Mar 2022
- First submitted
- 16 Mar 2022
- Last updated
- 25 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Different Tamponade Eyes on IOL-capsular Complex After Cataract Surgery Combined With Vitrectomy
- ClinicalTrials.gov ID
- NCT05296486
- Acronym / sponsor ID
- IOL with different tamponade
- Conditions
- Cataract, Vitreoretinal Abnormality
- Keywords
- Various Types of intravitreal tamponade materials
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 25 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| phacovitrectomy surgery with silicone oil tamponade | Experimental | Procedure: phacovitrectomy surgery with silicone oil tamponadepatients who had phacovitrectomy surgery with silicone oil tamponade.The patients diagnosed cataract The patients' ages are over 50. |
| phacovitrectomy surgery with gas tamponade | Experimental | Procedure: phacovitrectomy surgery with gas tamponadepatients who had phacovitrectomy surgery with gas tamponade.The patients diagnosed cataract The patients' ages are over 50. |
| phacovitrectomy surgery with balanced saline solution tamponade | Experimental | Procedure: phacovitrectomy surgery with balanced saline solution tamponadepatients who had phacovitrectomy surgery with balanced saline solution tamponade.The patients diagnosed cataract The patients' ages are over 50. |
| phacoemulsifacation surgery without vitrectomy | Experimental | Procedure: phacoemulsifacation surgery without vitrectomypatients who had phacoemulsifacation surgery without vitrectomy.The patients diagnosed cataract The patients' ages are over 50. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with other type of cataract
- Patients have severe complications in the surgery and after surgery
- Patients have other severe diseases of eyes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phacovitrectomy surgery with silicone oil tamponadePatients in this study will receive phacovitrectomy surgery with silicone oil tamponade. | Procedure or surgery | phacovitrectomy surgery with silicone oil tamponade |
| phacovitrectomy surgery with gas tamponadePatients in this study will receive phacovitrectomy surgery with gas tamponade | Procedure or surgery | phacovitrectomy surgery with gas tamponade |
| phacovitrectomy surgery with balanced saline solution tamponadePatients in this study will receive phacovitrectomy surgery with balanced saline solution tamponade | Procedure or surgery | phacovitrectomy surgery with balanced saline solution tamponade |
| phacoemulsifacation surgery without vitrectomyPatients in this study will receive phacoemulsifacation surgery without vitrectomy. | Procedure or surgery | phacoemulsifacation surgery without vitrectomy |
Primary outcome
The position of IOL
Time frame: The 1st day after surgery
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
Time frame: The 1st week after surgery
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
Time frame: The 1st month after surgery
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
Time frame: The 3rd month after surgery
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）
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yune Zhao, MD contact
Yune Zhao study director
Ophthalmology and Optometry Hospital
Questions about this trial
What is this clinical trial studying?
A study testing phacovitrectomy surgery with silicone oil tamponade, phacovitrectomy surgery with gas tamponade and phacovitrectomy surgery with balanced saline solution tamponade in people with Cataract and Vitreoretinal Abnormality, run by Wenzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pingjun Chang (18868410303, 364669877@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The position of IOL (time frame: The 1st day after surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022.