Primary Disease: Cataract1118NCT01693211
Prospective Evaluation of Circularity and Diameter of Femtosecond Laser Versus Manual Anterior Capsulotomy in Singapore National Eye Centre
A study testing Femtosecond Laser (VICTUS™ Femtosecond Laser Platform) and Manual (CCC technique with Utrata forceps) in people with Primary Disease: Cataract, run by Technolas Perfect Vision GmbH at 1 site in Singapore.
Trial summary
This is a prospective, randomized study evaluating the circularity of the anterior capsulotomy performed by the VICTUS femtosecond work station (Group A) versus the manual capsulotomy (Group B) of a minimum of 22 eyes and maximum of 30 eyes per group diagnosed with cataract, scheduled to undergo removal by… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Disease: Cataract
- What is being tested?
- Femtosecond Laser (VICTUS™ Femtosecond Laser Platform) and Manual (CCC technique with Utrata forceps)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSingapore
- Study dates
- Sep 2012to Jun 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting patients undergoing phacoemulsification and IOL implant surgery for cataract, the diagnosis of which has been confirmed by another investigator.
- Clear cornea media
- Pupil must be able to dilate to at least 6mm in diameter measured with the pupil gauge
Who cannot join
- Pre-existing posterior capsule rupture Difference between maximum and minimum K-values must not be more than 5 D. The maximum K- value may not exceed 60 D and the minimal value may not be smaller than 37 D.
- Corneal disease or pathology that precludes transmission of laser wavelength or distortion of laser light.
- Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally.
- Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
- Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
- Patients with disorders of the ocular muscle, such as nystagmus or strabismus Keratoconus
- ACD < 1.8 mm or ACD > 4.5 mm
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, randomized study evaluating the circularity of the anterior capsulotomy performed by the VICTUS femtosecond work station (Group A) versus the manual capsulotomy (Group B) of a minimum of 22 eyes and maximum of 30 eyes per group diagnosed with cataract, scheduled to undergo removal by phacoemulsification with intraocular lens implantation in SNEC.
The primary study end point is to determine if the circularity of the created rhexis is better in Group A as compared to Group B.
The secondary study end point is to determine the diameter of rhexis is more precise and reproducible in Group A as compared to Group B.
Read the detailed description
This clinical study is a controlled, open, randomized, prospective, single-centre, single-surgeon eye study to determine the precision of intraocular cuts for anterior capsulotomy in connection to cataract surgery and IOL implantation. The cuts are applied by means of the VICTUS femtosecond laser system using a cylindrical cut pattern with diameter and height dependent on anterior chamber depth, pupil diameter and ocular lens size for Group A and the manual surgery technique for Group B.
The allocation of the surgery technique will be randomized between the study patient. Each surgery technique represents a study group. In Group A the anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery. Group B acts as a control group where the capsulotomy as well as the lens fragmentation is performed manually.
The hypothesis of the study is that by means of intraocular, laser-induced cuts, circularity of the capsulotomy can be improved in a safe and effective way.
A detailed pre-operative examination will ensure that every interested and willing patient fulfils the inclusion criteria of this study. Post-operative examinations, which should document the success of the treatment, are to be carried out after 1-day, 1-week, 1-month.
- Conditions
- Primary Disease: Cataract
- Being tested
- Femtosecond Laser (VICTUS™ Femtosecond Laser Platform), Manual (CCC technique with Utrata forceps)
- Keywords
- femtosecond laser, cataract, control study, prospective
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femtosecond Laser (VICTUS™ Femtosecond Laser Platform)Device
Capsulotomy and pre-fragmentation of the nucleus are performed by the femtosecond laser.
Manual (CCC technique with Utrata forceps)Device
Capsulorhexis and pre-fragmentation are performed manually.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Capsulorhexis and pre-fragmentation of the nucleus are performed by the femtosecond laser. Receives: Device: Femtosecond Laser (VICTUS™ Femtosecond Laser Platform) |
| Group B | Active comparator | The Capulorhexis and nuclear fragmentation are performed manually. Receives: Device: Manual (CCC technique with Utrata forceps) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circularity of created rhexis
The primary study end point is to determine if the circularity of the created rhexis is better in Group A as compared to Group B. On the day of surgery immediately after the creation of the rhexis via an recorded surgical video.
Measured: intraoperative
Secondary outcomes (1)
Diameter of the created rhexis
The secondary study end point is to determine the diameter of rhexis is more precise and reproducible in Group A as compared to Group B. On the day of surgery immediately after the creation of the rhexis via an recorded surgical video.
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Disease: 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technolas Perfect Vision GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Soon Phaik Chee, Assoc Prof, Principal investigator, Singapore National Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01693211
- Sponsor's protocol ID
- 1118
- Acronym
- 1118
- Status last verified
- Jun 2014
- First submitted
- 14 Sep 2012
- Last updated
- 1 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Circularity and Diameter of Femtosecond Laser Versus Manual Anterior Capsulotomy in Singapore National Eye Centre
- ClinicalTrials.gov ID
- NCT01693211
- Acronym / sponsor ID
- 1118 / 1118
- Conditions
- Primary Disease: Cataract
- Keywords
- femtosecond laser, cataract, control study, prospective
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Technolas Perfect Vision GmbHIndustry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 26 Sep 2012 (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.
This is a prospective, randomized study evaluating the circularity of the anterior capsulotomy performed by the VICTUS femtosecond work station (Group A) versus the manual capsulotomy (Group B) of a minimum of 22 eyes and maximum of 30 eyes per group diagnosed with cataract, scheduled to undergo removal by phacoemulsification with intraocular lens implantation in SNEC.
The primary study end point is to determine if the circularity of the created rhexis is better in Group A as compared to Group B.
The secondary study end point is to determine the diameter of rhexis is more precise and reproducible in Group A as compared to Group B.
Detailed description
This clinical study is a controlled, open, randomized, prospective, single-centre, single-surgeon eye study to determine the precision of intraocular cuts for anterior capsulotomy in connection to cataract surgery and IOL implantation. The cuts are applied by means of the VICTUS femtosecond laser system using a cylindrical cut pattern with diameter and height dependent on anterior chamber depth, pupil diameter and ocular lens size for Group A and the manual surgery technique for Group B.
The allocation of the surgery technique will be randomized between the study patient. Each surgery technique represents a study group. In Group A the anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery. Group B acts as a control group where the capsulotomy as well as the lens fragmentation is performed manually.
The hypothesis of the study is that by means of intraocular, laser-induced cuts, circularity of the capsulotomy can be improved in a safe and effective way.
A detailed pre-operative examination will ensure that every interested and willing patient fulfils the inclusion criteria of this study. Post-operative examinations, which should document the success of the treatment, are to be carried out after 1-day, 1-week, 1-month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Femtosecond Laser (VICTUS™ Femtosecond Laser Platform)Capsulorhexis and pre-fragmentation of the nucleus are performed by the femtosecond laser. |
| Group B | Active comparator | Device: Manual (CCC technique with Utrata forceps)The Capulorhexis and nuclear fragmentation are performed manually. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Consenting patients undergoing phacoemulsification and IOL implant surgery for cataract, the diagnosis of which has been confirmed by another investigator.
- Clear cornea media
- Pupil must be able to dilate to at least 6mm in diameter measured with the pupil gauge
Key exclusion criteria (7 listed)
- Pre-existing posterior capsule rupture Difference between maximum and minimum K-values must not be more than 5 D. The maximum K- value may not exceed 60 D and the minimal value may not be smaller than 37 D.
- Corneal disease or pathology that precludes transmission of laser wavelength or distortion of laser light.
- Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally.
- Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
- Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye.
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 |
|---|---|---|
| Femtosecond Laser (VICTUS™ Femtosecond Laser Platform)Capsulotomy and pre-fragmentation of the nucleus are performed by the femtosecond laser. | Device | Group A |
| Manual (CCC technique with Utrata forceps)Capsulorhexis and pre-fragmentation are performed manually. | Device | Group B |
Primary outcome
Circularity of created rhexis
Time frame: intraoperative
The primary study end point is to determine if the circularity of the created rhexis is better in Group A as compared to Group B. On the day of surgery immediately after the creation of the rhexis via an recorded surgical video.
1 secondary outcome
Diameter of the created rhexis
Time frame: intraoperative
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 1 Jul 2014.
- SponsorLink 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.
Soon Phaik Chee, Assoc Prof principal investigator
Singapore National Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Femtosecond Laser (VICTUS™ Femtosecond Laser Platform) and Manual (CCC technique with Utrata forceps) in people with Primary Disease: Cataract, run by Technolas Perfect Vision GmbH at 1 site in Singapore.
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 3 inclusion and 7 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 1 Jul 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 Singapore. 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?
Circularity of created rhexis (time frame: intraoperative). 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 1 Jul 2014.