Age-related CataractNCT05255796
IOL-capsular Complex After Different Intraocular Lenses Implantation in Patients With High Myopia
A study testing one-piece and plate-haptic in people with Age-related Cataract, run by Wenzhou Medical University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Age-related Cataract
- What is being tested?
- one-piece and plate-haptic
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2022to 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 18 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 axial length over 26mm
- The patients' age over 18 years old
- The patients plan to receive cataract surgery in Eye hospital of Wenzhou Medical University
- The dialated pupils are over 6mm
- Patients are willing and able to complete the follow-ups
Who cannot join
- Patients with other types of cataract
- Patients have complications in the surgery and after surgery
- Patients have other severe diseases of eyes
Trial locations and contacts
1 site in 1 country.
Yune Zhao, MD contact
China1 site, 1 recruiting
- Recruiting
Eye Hospital of Wenzhou Medical College
Hangzhou, Zhejiang, 325027
Pingjun Chang, 18868410303, 364669877@qq.com
About this study
Official title: Influence of Different Intraocular Lenses on IOL-capsular Complex After Cataract Surgery in Patients With High Myopia: a Clinical Observation Based on SS-OCT
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. IOL decentration ≥ 0.4 mm or/and IOL tilt ≥7degree were considered clinically significant cause of poor post-surgery visual quality especially for optical sophisticated IOLs. This negative impact does not affect various types of IOLs equally. Several studies indicated that AL was an independent risk factor of IOL decentration and tilt for emmetropic or moderate myopic eyes. For patients with high myopia, they often have a longer axial length and a larger capsule diameter, which reduces the rotational stability of the IOL and may lead to tilt, decentration and displacement of IOL. Currently, there is no literature guidance to compare the results of cataract surgery combined various types of IOLs implantation in patients with high myopia. 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
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 for any design of IOL, 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 cause of poor post-surgery visual quality especially for optical sophisticated IOLs. This negative impact does not affect various types of IOLs equally. Several studies indicated that AL was an independent risk factor of IOL decentration and tilt for emmetropic or moderate myopic eyes. However, there is scarce evidence on characteristics and factors associated with clinically significant IOL decentration and tilt in highly myopic eyes. For patients with high myopia, they often have a longer axial length and a larger capsule diameter, which reduces the rotational stability of the IOL and may lead to tilt, decentration and displacement of IOL. Currently, there is no literature guidance to compare the results of cataract surgery combined various types of IOLs implantation in patients with high myopia. 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
- Age-related Cataract
- Being tested
- one-piece, plate-haptic
- Keywords
- High Myopia, Various Types of IOLs, The position of IOL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one-pieceProcedure or surgery
Patients underwent phacoemulsification cataract surgery with one-piece IOL implantation.
plate-hapticProcedure or surgery
Patients underwent phacoemulsification cataract surgery with plate-haptic IOL implantation.
| Study group | Role | What they receive |
|---|---|---|
| one-piece | Experimental | The patients' axial length is over 26 mm and are diagnosed age related cataract or complicated cataract. Receives: Procedure: one-piece |
| plate-haptic | Experimental | The patients' axial length is over 26 mm and are diagnosed age related cataract or complicated cataract. Receives: Procedure: plate-haptic |
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 and the process of capsule bending using CASIA2.
Measured: The 1st day after surgery
The position of IOL
Evaluation of the position of IOL through tilt, decentration and the process of capsule bending using CASIA2.
Measured: The 1st week after surgery
The position of IOL
Evaluation of the position of IOL through tilt, decentration and the process of capsule bending using CASIA2.
Measured: The 1st month after surgery
The position of IOL
Evaluation of the position of IOL through tilt, decentration and the process of capsule bending using CASIA2.
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 Feb 2022
- Study start7 Jan 2022
- Primary completionAug 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related 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
- 40 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
- NCT05255796
- Sponsor's protocol ID
- 20211213CTR
- Status last verified
- Feb 2022
- First submitted
- 13 Dec 2021
- Last updated
- 25 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Different Intraocular Lenses on IOL-capsular Complex After Cataract Surgery in Patients With High Myopia: a Clinical Observation Based on SS-OCT
- ClinicalTrials.gov ID
- NCT05255796
- Acronym / sponsor ID
- 20211213CTR
- Conditions
- Age-related Cataract
- Keywords
- High Myopia, Various Types of IOLs, The position of IOL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 25 Feb 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.
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. IOL decentration ≥ 0.4 mm or/and IOL tilt ≥7degree were considered clinically significant cause of poor post-surgery visual quality especially for optical sophisticated IOLs. This negative impact does not affect various types of IOLs equally. Several studies indicated that AL was an independent risk factor of IOL decentration and tilt for emmetropic or moderate myopic eyes. For patients with high myopia, they often have a longer axial length and a larger capsule diameter, which reduces the rotational stability of the IOL and may lead to tilt, decentration and displacement of IOL. Currently, there is no literature guidance to compare the results of cataract surgery combined various types of IOLs implantation in patients with high myopia. 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
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 for any design of IOL, 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 cause of poor post-surgery visual quality especially for optical sophisticated IOLs. This negative impact does not affect various types of IOLs equally. Several studies indicated that AL was an independent risk factor of IOL decentration and tilt for emmetropic or moderate myopic eyes. However, there is scarce evidence on characteristics and factors associated with clinically significant IOL decentration and tilt in highly myopic eyes. For patients with high myopia, they often have a longer axial length and a larger capsule diameter, which reduces the rotational stability of the IOL and may lead to tilt, decentration and displacement of IOL. Currently, there is no literature guidance to compare the results of cataract surgery combined various types of IOLs implantation in patients with high myopia. 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
- 2
| Arm | Type | Receives |
|---|---|---|
| one-piece | Experimental | Procedure: one-pieceThe patients' axial length is over 26 mm and are diagnosed age related cataract or complicated cataract. |
| plate-haptic | Experimental | Procedure: plate-hapticThe patients' axial length is over 26 mm and are diagnosed age related cataract or complicated cataract. |
Who may qualify
- Ages
- 18 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 axial length over 26mm
- The patients' age over 18 years old
- The patients plan to receive cataract surgery in Eye hospital of Wenzhou Medical University
- The dialated pupils are over 6mm
- Patients are willing and able to complete the follow-ups
Key exclusion criteria (3 listed)
- Patients with other types of cataract
- Patients have 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 |
|---|---|---|
| one-piecePatients underwent phacoemulsification cataract surgery with one-piece IOL implantation. | Procedure or surgery | one-piece |
| plate-hapticPatients underwent phacoemulsification cataract surgery with plate-haptic IOL implantation. | Procedure or surgery | plate-haptic |
Primary outcome
The position of IOL
Time frame: The 1st day after surgery
Evaluation of the position of IOL through tilt, decentration and the process of capsule bending using CASIA2.
The position of IOL
Time frame: The 1st week after surgery
Evaluation of the position of IOL through tilt, decentration and the process of capsule bending using CASIA2.
The position of IOL
Time frame: The 1st month after surgery
Evaluation of the position of IOL through tilt, decentration and the process of capsule bending using CASIA2.
The position of IOL
Time frame: The 3rd month after surgery
Evaluation of the position of IOL through tilt, decentration and the process of capsule bending using CASIA2.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2022.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing one-piece and plate-haptic in people with Age-related Cataract, run by Wenzhou Medical University at 1 site in China.
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 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Feb 2022.