Visual OutcomesNCT03351894
Comparison of Clinical Outcomes in Ziemer Femtosecond Versus Conventional Phacoemulsification Surgery
A study testing Femtosecond laser assisted cataract surgery and Conventional phacoemulsification in people with Visual Outcomes, run by Singapore Eye Research Institute at 1 site in Singapore.
Trial summary
This study is aimed to compare the clinical outcomes in Ziemer LDV Z8 femtosecond laser-assisted cataract surgery versus conventional phacoemulsification cataract surgery Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Visual Outcomes
- What is being tested?
- Femtosecond laser assisted cataract surgery and Conventional phacoemulsification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2015to 28 Feb 2024
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A cataract will be defined as clouding of the lens that interferes with normal vision.
- Not relevant, as study not on cancer patients.
- Only patients older than 50 years will be included, as cataracts develops with increasing age. No gender criteria are applied.
- Only individuals with the mental capacity to provide informed consent with be included.
- More specifically, all the following inclusion criteria must be met:
- Patients have medically dilated pupil size of at least 4.0mm.
- Patients are willing and able to sign a written Informed Consent Form prior to any study-specific procedures.
- Patients are willing and able to return for scheduled follow-up examinations for 12 months after the cataract surgery.
Who cannot join
- Patients with prior history of pseudoexfoliation syndrome.
- Patients with a prior history of glaucoma filtration surgery.
- Patients with optic atrophy.
- Patients with ocular pathology or disease (including pupil pathology such as fixated pupils) that might confound the outcome or increase the risk of adverse event..
- Patients with a prior history of vitrectomy.
- Patients with a prior history of cataract or refractive lens surgery
Show all 14Show fewer
- Patients with central corneal scarring.
- Patients with residual, recurrent, active or uncontrolled eyelid disease.
- Patients with significant corneal asymmetry or irregular topography.
- Patients with anterior segment pathology.
- Patients with any corneal abnormality
- Patients with any progressive retinal disease or subjects with a history or evidence of retinal vascular occlusion and/or hypercoagulability, because of the risks associated with high pressures during suction application.
- Patients with amblyopia or strabismus or those who are at risk for developing strabismus postoperatively as determined by corneal light reflex and cover-uncover testing.
- Patients who are pregnant, lactating, of child-bearing potential and not practising a medically approved method of birth control, or planning to become pregnant during the course of the trial, and patients with other conditions associated with fluctuation of hormones that could lead to refractive changes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Clinical Outcomes in Ziemer LDV Z8 Femtosecond Laser-assisted Cataract Surgery
This study is aimed to compare the clinical outcomes in Ziemer LDV Z8 femtosecond laser-assisted cataract surgery versus conventional phacoemulsification cataract surgery
Read the detailed description
This study is aimed to compare the clinical outcomes in Ziemer LDV Z8 femtosecond laser-assisted cataract surgery versus conventional phacoemulsification cataract surgery. This study will be a non-inferiority study and ninety-five patients will be recruited.
- Conditions
- Visual Outcomes
- Being tested
- Femtosecond laser assisted cataract surgery, Conventional phacoemulsification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Femtosecond laser assisted cataract surgeryProcedure or surgery
Ziemer Z8 femtosecond laser assisted cataract surgery
Conventional phacoemulsificationProcedure or surgery
conventional phacoemulsification with infinity phaco
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Placebo comparator | Conventional phacoemulsification surgery Receives: Procedure: Conventional phacoemulsification |
| Femtosecond laser | Active comparator | Ziemer femtosecond laser assisted cataract surgery Intervention: Ziemer femtosecond laser assisted cataract surgery Receives: Procedure: Femtosecond laser assisted cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative dissipated energy (CDE)
Energy from phaco machine
Measured: 12 months
Secondary outcomes (8)
Best corrected distance visual acuity (snellen)
LogMar VA
Measured: 12 months
Refraction (diopters)
Sphere and cyl, manifest
Measured: 12 months
Corneal endothelial count
cells/mm2
Measured: 12 months
Anterior chamber inflammation (by flaremeter)
pixels
Measured: 12 months
Effective intraocular lens position (UBM)
lens tilt
Measured: 12 months
Intraocular pressure (mmHg)
mmHg
Measured: 12 months
Patient surgery experiences (questionnaire)
Qualitative patient experience
Measured: 12 months
Optic disc nerve(OCT)
RNFL
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study startAug 2015
- Primary completion28 Feb 2024
- Study completion28 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual OutcomesStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore Eye Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jodhbir Mehta, Singapore Eye Research Institute
- Investigators
- Jodhbir Mehta, Principal investigator, Singapore National Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351894
- Sponsor's protocol ID
- SERI R1249/55/2015
- Status last verified
- May 2025
- First submitted
- 19 Jul 2016
- Last updated
- 29 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Outcomes in Ziemer LDV Z8 Femtosecond Laser-assisted Cataract Surgery
- ClinicalTrials.gov ID
- NCT03351894
- Acronym / sponsor ID
- SERI R1249/55/2015
- Conditions
- Visual Outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Singapore Eye Research InstituteUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 24 Nov 2017 (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.
This study is aimed to compare the clinical outcomes in Ziemer LDV Z8 femtosecond laser-assisted cataract surgery versus conventional phacoemulsification cataract surgery
Detailed description
This study is aimed to compare the clinical outcomes in Ziemer LDV Z8 femtosecond laser-assisted cataract surgery versus conventional phacoemulsification cataract surgery. This study will be a non-inferiority study and ninety-five patients will be recruited.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | Placebo comparator | Procedure: Conventional phacoemulsificationConventional phacoemulsification surgery |
| Femtosecond laser | Active comparator | Procedure: Femtosecond laser assisted cataract surgeryZiemer femtosecond laser assisted cataract surgery Intervention: Ziemer femtosecond laser assisted cataract surgery |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- A cataract will be defined as clouding of the lens that interferes with normal vision.
- Not relevant, as study not on cancer patients.
- Only patients older than 50 years will be included, as cataracts develops with increasing age. No gender criteria are applied.
- Only individuals with the mental capacity to provide informed consent with be included.
- Patients have medically dilated pupil size of at least 4.0mm.
Key exclusion criteria (14 listed)
- Patients with prior history of pseudoexfoliation syndrome.
- Patients with a prior history of glaucoma filtration surgery.
- Patients with optic atrophy.
- Patients with ocular pathology or disease (including pupil pathology such as fixated pupils) that might confound the outcome or increase the risk of adverse event..
- Patients with a prior history of vitrectomy.
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 assisted cataract surgeryZiemer Z8 femtosecond laser assisted cataract surgery | Procedure or surgery | Femtosecond laser |
| Conventional phacoemulsificationconventional phacoemulsification with infinity phaco | Procedure or surgery | Conventional |
Primary outcome
Cumulative dissipated energy (CDE)
Time frame: 12 months
Energy from phaco machine
8 secondary outcomes
Best corrected distance visual acuity (snellen)
Time frame: 12 months
Refraction (diopters)
Time frame: 12 months
Corneal endothelial count
Time frame: 12 months
Anterior chamber inflammation (by flaremeter)
Time frame: 12 months
Effective intraocular lens position (UBM)
Time frame: 12 months
Intraocular pressure (mmHg)
Time frame: 12 months
Patient surgery experiences (questionnaire)
Time frame: 12 months
Optic disc nerve(OCT)
Time frame: 12 months
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 29 May 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Visual Outcomes
Active, not recruitingObservational study
Visual and Refractive Outcomes Following Stream Light Photorefractive Keratectomy (55μm Epithelial Removal) Versus Conventional Photorefractive Keratectomy
Photorefractive Keratectomy
Not yet recruitingObservational study
PureSee/Odyssey Mix-and-Match IOL
Cataract
Active, not recruitingPhase 4
Odyssey Evaluation in Post LASIK Patients
Cataract
Not yet recruiting
The Effect of Bitewing Radiography on Outcomes and Costs of Treating Caries in Permanent Teeth
Dental Caries, Teeth Loss
RecruitingPhase 2
Bevonescein for Improved Intraoperative Nerve Visualization to Improve Voice Outcomes in Thyroidectomy Patients
Head and Neck Disorder, Head and Neck Cancer
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.
Jodhbir Mehta principal investigator
Singapore National Eye Centre
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 assisted cataract surgery and Conventional phacoemulsification in people with Visual Outcomes, run by Singapore Eye Research Institute 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 8 inclusion and 14 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 29 May 2025. 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. Some participants in this study may receive a placebo. 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?
Cumulative dissipated energy (CDE) (time frame: 12 months). 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 29 May 2025.