CataractNCT02138123
Intraocular Lens-shell Technique in Phacoemulsification
A study testing IOL-shell technique and Conventional procedure in people with Cataract and Pseudoaphakia, run by Sun Yat-sen University at 1 site in China.
Trial summary
In this study, the investigators introduce a surgical procedure called "IOL-shell technique" in the purpose of reduce complications of surgeries for dense cataract, and report a prospective randomized controlled study aiming at assessing efficacy and safety of the IOL-shell technique, which showed that the new… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Cataract, Pseudoaphakia
- What is being tested?
- IOL-shell technique and Conventional procedure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Dec 2011to Jun 2013
- 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
- Aged 50 years or above
- Dense cataract cases were defined as eyes in which the nuclear color was graded IV or V according to the Lens Opacities Classification System III (LOCS III). Special attention was paid in selecting cases without apparent posterior cortical layer.
- No central corneal opacification
- Pupil diameter >= 7 mm after full pharmacological dilation in preoperative assessment
- A preoperative central endothelial cell count of >= 1500 cells/mm2.
Who cannot join
- Participants with previous intraocular surgery
- Abnormal lens zonules
- Glaucoma
- High myopia (>-6.0 Diopters)
- Pseudoexfoliation
- Uveitis
- Diabetes mellitus
- Those who were not able to come for follow-up visits.
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Ophthalmic Center,Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: Intraocular Lens-Shell Technique: An Adjustment of Surgical Procedure Makes Differences in Treating Dense Nucleus Cataract
In this study, the investigators introduce a surgical procedure called "IOL-shell technique" in the purpose of reduce complications of surgeries for dense cataract, and report a prospective randomized controlled study aiming at assessing efficacy and safety of the IOL-shell technique, which showed that the new procedure offered a safer way for hard cataract surgery over the conventional phacoemulsification procedure without compromise in efficacy.
Read the detailed description
A Prospective, randomized controlled study of 80 eyes with dense nucleus were enrolled. Patients were assigned to two groups: Group I: IOL was traditionally implanted after all nuclear fragments were completely removed, while in Group II, IOL was innovatively implanted in the bag before last residual nuclear fragment was removed. This novel adjusted surgical procedure, featured by using IOL as a protective barrier (named "IOL-shell technique"), not just as a refractive alternative, was conceptual different from the traditional step-by-step procedure. Clinical examinations including uncorrected visual acuity, central corneal thickness (CCT), temporal clear corneal thickness and the corneal endothelial cell density were carried out.
- Conditions
- Cataract, Pseudoaphakia
- Being tested
- IOL-shell technique, Conventional procedure
- Keywords
- dense cataract, phacoemulsification, lens-shell technique, intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOL-shell techniqueProcedure or surgery
Phacoemulsification was performed with the same device and handpieces, using the same phaco chop technique as in the conventional procedure group. What was different was that before the emulsification of the last nuclear fragment, cohesive viscoelastic material was injected below the nuclear fragment and a foldable IOL was implanted into the well inflated capsular bag posterior to the nuclear fragment. The remaining last piece of nuclear fragment was then emulsified and removed within the capsular bag.
Conventional procedureProcedure or surgery
In this procedure, a IOL was not implanted until all the nuclear fragments were removed.
| Study group | Role | What they receive |
|---|---|---|
| IOL-shell technique | Experimental | In this group, before the emulsification of the last nuclear fragment, cohesive viscoelastic material was injected below the nuclear fragment and a foldable IOL was implanted into the well inflated capsular bag posterior to the nuclear fragment. The remaining last piece of nuclear fragment was then emulsified and removed within the capsular bag. Receives: Procedure: IOL-shell technique |
| Conventional procedure | Active comparator | In this group, a Sensar IOL (AMO Laboratories) was implanted in the capsular bag with the injector system after the lens material was completely removed. The nuclear fragmentation was performed using the Phaco-chop technique, which was then followed by ultrasound emulsification of the nuclear fragments piece by piece. Due to lack of cortical shell within the capsular bag, special care was taken to carry out the emulsification of the last nuclear fragment at a relatively more anterior anatomical position between the iris plan and the anterior chamber. Receives: Procedure: Conventional procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central corneal endothelial cell loss
Central corneal endothelial cell loss was calculated by subtracting postoperative corneal endothelial cell density from the preoperative baseline level.
Measured: one month
Secondary outcomes (1)
central cornea thickness
The temporal corneal thickness and central corneal thickness were measured using the manual measurement scale in the scanning pictures of anterior segment optical coherence tomography preoperatively and at each postoperative visit.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startDec 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
- Investigators
- Yizhi Liu, Ph.D., Study chair, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138123
- Sponsor's protocol ID
- CCPMOH2010-China5
- Status last verified
- Jun 2014
- First submitted
- 12 May 2014
- Last updated
- 9 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shah PA, Yoo S. Innovations in phacoemulsification technology. Curr Opin Ophthalmol. 2007 Feb;18(1):23-6. doi: 10.1097/ICU.0b013e328011f9d0.
PubMed 17159443Luo L, Lin H, He M, Congdon N, Yang Y, Liu Y. Clinical evaluation of three incision size-dependent phacoemulsification systems. Am J Ophthalmol. 2012 May;153(5):831-839.e2. doi: 10.1016/j.ajo.2011.10.034. Epub 2012 Feb 4.
PubMed 22310081Hwang HS, Kim EC, Kim MS. Drill-and-crack technique for nuclear disassembly of hard nucleus. J Cataract Refract Surg. 2010 Oct;36(10):1627-30. doi: 10.1016/j.jcrs.2010.08.003.
PubMed 20870105Luo L, Lin H, Chen W, Qu B, Zhang X, Lin Z, Chen J, Liu Y. Intraocular lens-shell technique: adjustment of the surgical procedure leads to greater safety when treating dense nuclear cataracts. PLoS One. 2014 Nov 17;9(11):e112663. doi: 10.1371/journal.pone.0112663. eCollection 2014.
PubMed 25401512
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraocular Lens-Shell Technique: An Adjustment of Surgical Procedure Makes Differences in Treating Dense Nucleus Cataract
- ClinicalTrials.gov ID
- NCT02138123
- Acronym / sponsor ID
- CCPMOH2010-China5
- Conditions
- Cataract, Pseudoaphakia
- Keywords
- dense cataract, phacoemulsification, lens-shell technique, intraocular lens
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- National Natural Science Foundation of China
- Study start
- Dec 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 14 May 2014 (estimated)
- 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.
In this study, the investigators introduce a surgical procedure called "IOL-shell technique" in the purpose of reduce complications of surgeries for dense cataract, and report a prospective randomized controlled study aiming at assessing efficacy and safety of the IOL-shell technique, which showed that the new procedure offered a safer way for hard cataract surgery over the conventional phacoemulsification procedure without compromise in efficacy.
Detailed description
A Prospective, randomized controlled study of 80 eyes with dense nucleus were enrolled. Patients were assigned to two groups: Group I: IOL was traditionally implanted after all nuclear fragments were completely removed, while in Group II, IOL was innovatively implanted in the bag before last residual nuclear fragment was removed. This novel adjusted surgical procedure, featured by using IOL as a protective barrier (named "IOL-shell technique"), not just as a refractive alternative, was conceptual different from the traditional step-by-step procedure. Clinical examinations including uncorrected visual acuity, central corneal thickness (CCT), temporal clear corneal thickness and the corneal endothelial cell density were carried out.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IOL-shell technique | Experimental | Procedure: IOL-shell techniqueIn this group, before the emulsification of the last nuclear fragment, cohesive viscoelastic material was injected below the nuclear fragment and a foldable IOL was implanted into the well inflated capsular bag posterior to the nuclear fragment. The remaining last piece of nuclear fragment was then emulsified and removed within the capsular bag. |
| Conventional procedure | Active comparator | Procedure: Conventional procedureIn this group, a Sensar IOL (AMO Laboratories) was implanted in the capsular bag with the injector system after the lens material was completely removed. The nuclear fragmentation was performed using the Phaco-chop technique, which was then followed by ultrasound emulsification of the nuclear fragments piece by piece. Due to lack of cortical shell within the capsular bag, special care was taken to carry out the emulsification of the last nuclear fragment at a relatively more anterior anatomical position between the iris plan and the anterior chamber. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 50 years or above
- Dense cataract cases were defined as eyes in which the nuclear color was graded IV or V according to the Lens Opacities Classification System III (LOCS III). Special attention was paid in selecting cases without apparent posterior cortical layer.
- No central corneal opacification
- Pupil diameter >= 7 mm after full pharmacological dilation in preoperative assessment
- A preoperative central endothelial cell count of >= 1500 cells/mm2.
Key exclusion criteria (8 listed)
- Participants with previous intraocular surgery
- Abnormal lens zonules
- Glaucoma
- High myopia (>-6.0 Diopters)
- Pseudoexfoliation
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 |
|---|---|---|
| IOL-shell techniquePhacoemulsification was performed with the same device and handpieces, using the same phaco chop technique as in the conventional procedure group. What was different was that before the emulsification of the last nuclear fragment, cohesive viscoelastic material was injected below the nuclear fragment and a foldable IOL was implanted into the well inflated capsular bag posterior to the nuclear fragment. The remaining last piece of nuclear fragment was then emulsified and removed within the capsular bag. | Procedure or surgery | IOL-shell technique |
| Conventional procedureIn this procedure, a IOL was not implanted until all the nuclear fragments were removed. | Procedure or surgery | Conventional procedure |
Primary outcome
Central corneal endothelial cell loss
Time frame: one month
Central corneal endothelial cell loss was calculated by subtracting postoperative corneal endothelial cell density from the preoperative baseline level.
1 secondary outcome
central cornea thickness
Time frame: one month
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 9 Jun 2014.
- Background: PubMed 17159443Shah PA, Yoo S. Innovations in phacoemulsification technology. Curr Opin Ophthalmol. 2007 Feb;18(1):23-6. doi: 10.1097/ICU.0b013e328011f9d0.
- Background: PubMed 22310081Luo L, Lin H, He M, Congdon N, Yang Y, Liu Y. Clinical evaluation of three incision size-dependent phacoemulsification systems. Am J Ophthalmol. 2012 May;153(5):831-839.e2. doi: 10.1016/j.ajo.2011.10.034. Epub 2012 Feb 4.
- Background: PubMed 20870105Hwang HS, Kim EC, Kim MS. Drill-and-crack technique for nuclear disassembly of hard nucleus. J Cataract Refract Surg. 2010 Oct;36(10):1627-30. doi: 10.1016/j.jcrs.2010.08.003.
- Derived from this study: PubMed 25401512Luo L, Lin H, Chen W, Qu B, Zhang X, Lin Z, Chen J, Liu Y. Intraocular lens-shell technique: adjustment of the surgical procedure leads to greater safety when treating dense nuclear cataracts. PLoS One. 2014 Nov 17;9(11):e112663. doi: 10.1371/journal.pone.0112663. eCollection 2014.
- Homepage of Zhongshan Ophthalmic CenterLink provided by the sponsor.
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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.
Yizhi Liu, Ph.D. study chair
Zhongshan Ophthalmic Center, Sun Yat-sen 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 IOL-shell technique and Conventional procedure in people with Cataract and Pseudoaphakia, run by Sun Yat-sen 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 8 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 9 Jun 2014. 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?
Central corneal endothelial cell loss (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02138123, which also lists 4 linked publications.
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 9 Jun 2014; AzTrials last refreshed its copy on 2 Nov 2026.