CataractNCT03584139
IRIS Hook Assisted Phacoemulsification in Vitrectomized Eyes
A study testing IRIS HOOK and TRADITION in people with Cataract and Vitrectomy, run by Second Affiliated Hospital of Xi'an Jiaotong University at 1 site in China.
Trial summary
Although phacoemulsification in previously vitrectomized eyes is a relatively safe procedure comparing with extracapsular cataract surgery, it is still more challenging than in eyes without previous vitrectomy because of the anatomical differences after PPV. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Cataract, Vitrectomy
- What is being tested?
- IRIS HOOK and TRADITION
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 31 Dec 2019
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with visually significant cataract following PPV
- After PPV vitreous substitutes were air / gas (Perfluoropropane:C3F8) or BSS,
- After PPV if vitreous substitute was silicone oil, that should be removed at least 3 months.
- The duration between PPV / silicone oil remove and phacoemulsification should more than 3 months
- Willing and able to comply with clinic visits and study-related procedures
- Provide signed informed consent
Who cannot join
- Eyes with a history of acute angle-closure glaucoma, trauma,
- Eyes with a clinically dislocated or subluxated lens.
- Active ocular or periocular infection in the study eye
- Uncontrolled Blood Pressure
- Pregnant or breast-feeding women
- Participation in another simultaneous medical investigator or trial
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Ophthalmology, Second affiliated hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710004
About this study
Although phacoemulsification in previously vitrectomized eyes is a relatively safe procedure comparing with extracapsular cataract surgery, it is still more challenging than in eyes without previous vitrectomy because of the anatomical differences after PPV. Intraoperative difficulties such as abnormal anterior chamber deepening, unstable posterior capsules, and weakened zonules have been reported.
The investigators aim to evaluate the efficacy and safety of a new simple iris hook assisted maneuver in phacoemulsification, then compare the incidence of intraoperative and postoperative complications of this technique with traditional phacoemulsification and phacoemulsification with 25-gauge vitreous irrigation. The latter two surgery methods are currently popular for cataract in vitrectomized eyes.
Read the detailed description
With the continuous evolution in vitrectomy techniques and instrumentation, an increasing number of vitreorential disorders are being successfully managed with pars plana vitrectomy (PPV). Cataract is one of the most common complications seen in phakic patients following PPV, and the incidence of it ranges from 4 to 80%, even up to 100% in various studies.
Although phacoemulsification in previously vitrectomized eyes is a relatively safe procedure comparing with extracapsular cataract surgery, it is still more challenging than in eyes without previous vitrectomy because of the anatomical differences after PPV. Intraoperative difficulties such as abnormal anterior chamber deepening, unstable posterior capsules, and weakened zonules have been reported.
The investigators aim to evaluate the efficacy and safety of a new simple iris hook assisted maneuver in phacoemulsification, then compare the incidence of intraoperative and postoperative complications of this technique with traditional phacoemulsification and phacoemulsification with 25-gauge vitreous irrigation. The latter two surgery methods are currently popular for cataract in vitrectomized eyes.
- Conditions
- Cataract, Vitrectomy
- Being tested
- IRIS HOOK, TRADITION
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IRIS HOOKDevice
iris hook assisted maneuver in phacoemulsification
TRADITIONDevice
traditional phacoemulsification or phacoemulsification with 25-gauge vitreous irrigation
| Study group | Role | What they receive |
|---|---|---|
| IRIS HOOK | Experimental | iris hook assisted maneuver in phacoemulsification Receives: Device: IRIS HOOK |
| TRADITION | Active comparator | traditional phacoemulsification or phacoemulsification with 25-gauge vitreous irrigation Receives: Device: TRADITION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability of anterior chamber and pupil
The traditional phacoemulsification in vitrectomized eyes usually with more Intraoperative difficulties such as abnormal anterior chamber deepening and unstable pupil. To evaluate whether the new method will increase the stability of anterior chamber and pupil.
Measured: Intraoperative
Time of operation
To evaluate whether the new method will shorten the operation time
Measured: Intraoperative
Cumulative dissipated energy (CDE)
To evaluate whether the new method will decrease CDE. CDE reflect the damage of phacoemulsification to the eye, It can be acquired automatically from the phacoemulsification machine. The unit of CDE is mJ.
Measured: Intraoperative
Secondary outcomes (4)
The presence of intraoperative complications
The incidence of complications, including infusion deprivation syndrome, anterior capsulorhexis extension, iris trauma, descemets detachment, posterior capsular defect, nucleus drop, etc
Measured: Intraoperative
Visual acuity (VA)
To evaluate whether the surgery can effectively increase VA.
Measured: 3 months after opreation
Intraocular pressure(IOP)
The traditional phacoemulsification in vitrectomized eyes usually cause low IOP in the early stage, and sometimes induce detachment of choroid. To evaluate whether the new method will avoid the low IOP in the early stage.
Measured: 3 months after opreation
The presence of postoperative complications
The incidence of complications, including corneal edema, cystoid macular edema, etc.
Measured: 3 months after opreation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start1 Apr 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bai Ling, Second Affiliated Hospital of Xi'an Jiaotong University
- Investigators
- Ling Bai, MD,PhD, Principal investigator, Second affiliated hospital of Xian Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584139
- Sponsor's protocol ID
- IRIS hook
- Status last verified
- Mar 2020
- First submitted
- 21 May 2018
- Last updated
- 6 Mar 2020
- Results posted
- No
- Data monitoring committee
- 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 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IRIS Hook Assisted Phacoemulsification in Vitrectomized Eyes
- ClinicalTrials.gov ID
- NCT03584139
- Acronym / sponsor ID
- IRIS hook
- Conditions
- Cataract, Vitrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 12 Jul 2018 (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.
Although phacoemulsification in previously vitrectomized eyes is a relatively safe procedure comparing with extracapsular cataract surgery, it is still more challenging than in eyes without previous vitrectomy because of the anatomical differences after PPV. Intraoperative difficulties such as abnormal anterior chamber deepening, unstable posterior capsules, and weakened zonules have been reported.
The investigators aim to evaluate the efficacy and safety of a new simple iris hook assisted maneuver in phacoemulsification, then compare the incidence of intraoperative and postoperative complications of this technique with traditional phacoemulsification and phacoemulsification with 25-gauge vitreous irrigation. The latter two surgery methods are currently popular for cataract in vitrectomized eyes.
Detailed description
With the continuous evolution in vitrectomy techniques and instrumentation, an increasing number of vitreorential disorders are being successfully managed with pars plana vitrectomy (PPV). Cataract is one of the most common complications seen in phakic patients following PPV, and the incidence of it ranges from 4 to 80%, even up to 100% in various studies.
Although phacoemulsification in previously vitrectomized eyes is a relatively safe procedure comparing with extracapsular cataract surgery, it is still more challenging than in eyes without previous vitrectomy because of the anatomical differences after PPV. Intraoperative difficulties such as abnormal anterior chamber deepening, unstable posterior capsules, and weakened zonules have been reported.
The investigators aim to evaluate the efficacy and safety of a new simple iris hook assisted maneuver in phacoemulsification, then compare the incidence of intraoperative and postoperative complications of this technique with traditional phacoemulsification and phacoemulsification with 25-gauge vitreous irrigation. The latter two surgery methods are currently popular for cataract in vitrectomized eyes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IRIS HOOK | Experimental | Device: IRIS HOOKiris hook assisted maneuver in phacoemulsification |
| TRADITION | Active comparator | Device: TRADITIONtraditional phacoemulsification or phacoemulsification with 25-gauge vitreous irrigation |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- patients with visually significant cataract following PPV
- After PPV vitreous substitutes were air / gas (Perfluoropropane:C3F8) or BSS,
- After PPV if vitreous substitute was silicone oil, that should be removed at least 3 months.
- The duration between PPV / silicone oil remove and phacoemulsification should more than 3 months
- Willing and able to comply with clinic visits and study-related procedures
Key exclusion criteria (6 listed)
- Eyes with a history of acute angle-closure glaucoma, trauma,
- Eyes with a clinically dislocated or subluxated lens.
- Active ocular or periocular infection in the study eye
- Uncontrolled Blood Pressure
- Pregnant or breast-feeding women
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 |
|---|---|---|
| IRIS HOOKiris hook assisted maneuver in phacoemulsification | Device | IRIS HOOK |
| TRADITIONtraditional phacoemulsification or phacoemulsification with 25-gauge vitreous irrigation | Device | TRADITION |
Primary outcome
Stability of anterior chamber and pupil
Time frame: Intraoperative
The traditional phacoemulsification in vitrectomized eyes usually with more Intraoperative difficulties such as abnormal anterior chamber deepening and unstable pupil. To evaluate whether the new method will increase the stability of anterior chamber and pupil.
Time of operation
Time frame: Intraoperative
To evaluate whether the new method will shorten the operation time
Cumulative dissipated energy (CDE)
Time frame: Intraoperative
To evaluate whether the new method will decrease CDE. CDE reflect the damage of phacoemulsification to the eye, It can be acquired automatically from the phacoemulsification machine. The unit of CDE is mJ.
4 secondary outcomes
The presence of intraoperative complications
Time frame: Intraoperative
Visual acuity (VA)
Time frame: 3 months after opreation
Intraocular pressure(IOP)
Time frame: 3 months after opreation
The presence of postoperative complications
Time frame: 3 months after opreation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- 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.
Ling Bai, MD,PhD principal investigator
Second affiliated hospital of Xian Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IRIS HOOK and TRADITION in people with Cataract and Vitrectomy, run by Second Affiliated Hospital of Xi'an Jiaotong 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 6 Mar 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stability of anterior chamber and pupil (time frame: Intraoperative). The study lists 3 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 6 Mar 2020; AzTrials last refreshed its copy on 5 Nov 2026.