CataractNCT06649799
Comparative Study on Changes in Anterior Chamber Cytokines, Oxidative Stress, and Pupil Size After LenSx and Z8 Femtosecond Lasers
A study testing LenSx and Z8 in people with Cataract, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Femtosecond laser-assisted cataract surgery is rapidly gaining popularity. Among the 5 femtosecond laser platforms available at present for cataract surgery, the Femto LDV Z8 (Ziemer Ophthalmic Systems AG) is a high-frequency system and delivers energy pulses in nanojoule levels, while Lensx platform (Lensx, Alcon… Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cataract
- What is being tested?
- LenSx and Z8
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age related cataracts over 50 years old, nuclear grades II-III
Who cannot join
- Eye diseases: glaucoma, uveitis
- Systemic diseases: autoimmune diseases such as diabetes and rheumatism ③ Intraoperative complications: ④ Medication history: Over 1 month before surgery, systemic or local hormones, NASIDs ⑤ History of eye surgery (including YAG laser and fundus laser), trauma
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
ye Center, The Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Femtosecond laser-assisted cataract surgery is rapidly gaining popularity. Among the 5 femtosecond laser platforms available at present for cataract surgery, the Femto LDV Z8 (Ziemer Ophthalmic Systems AG) is a high-frequency system and delivers energy pulses in nanojoule levels, while Lensx platform (Lensx, Alcon Laboratories, Inc.) used a high-energy laser system. In femtosecond laser-assisted cataract surgery, the laser pretreatment is associated with breakdown of blood-aqueous barrier (BAB) associated with increased aqueous total prostaglandin, cytokines and Oxygen-free radicals concentration. The prostaglandin rise immediately after laser pretreatment is further thought to be the causative factor for the intraoperative miosis in femtosecond laser-assisted cataract surgery. However, the analysis of anterior chamber inflammatory factors, oxidative stress, and pupil size after femtosecond laser-assisted cataract surgery between different laser platforms has not been investigated in clinical studies. Understanding the cytokine and chemokine changes related to the laser pretreatment provides better insight into the inflammatory response in femtosecond laser-assisted cataract surgery.
- Conditions
- Cataract
- Being tested
- LenSx, Z8
- Keywords
- cataract; femtosecond laser; cytokines; oxidative stress; miosis;
- Medical subject headings
- Cataract, Miosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LenSxDevice
The patients in Group 1 conduct FLACS under LenSx
Z8Device
The patients in Group 1 conducted FLACS using Z8
| Study group | Role | What they receive |
|---|---|---|
| LenSx | Experimental | Not described Receives: Device: LenSx |
| Z8 | Placebo comparator | Not described Receives: Device: Z8 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PGE2
The concentrations of PGE2 in aqueous humor
Measured: through study completion, an average of half a year
cytokines (IL-1β、IL-6, IL-8、TNF-a)
The concentrations of cytokines (IL-1β、IL-6, IL-8、TNF-a) in aqueous humor
Measured: through study completion, an average of half a year
MDA
The concentrations of MDA in aqueous humor
Measured: through study completion, an average of half a year
Secondary outcomes (2)
central corneal thickness
The central corneal thickness was measured
Measured: through study completion, an average of half a year
central macular thickness
The central macular thickness was measured
Measured: through study completion, an average of half a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start1 Aug 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06649799
- Sponsor's protocol ID
- 2022-0672
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study on Changes in Anterior Chamber Cytokines, Oxidative Stress, and Pupil Size After LenSx and Z8 Femtosecond Lasers
- ClinicalTrials.gov ID
- NCT06649799
- Acronym / sponsor ID
- 2022-0672
- Conditions
- Cataract
- Keywords
- cataract; femtosecond laser; cytokines; oxidative stress; miosis;
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 21 Oct 2024 (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.
Femtosecond laser-assisted cataract surgery is rapidly gaining popularity. Among the 5 femtosecond laser platforms available at present for cataract surgery, the Femto LDV Z8 (Ziemer Ophthalmic Systems AG) is a high-frequency system and delivers energy pulses in nanojoule levels, while Lensx platform (Lensx, Alcon Laboratories, Inc.) used a high-energy laser system. In femtosecond laser-assisted cataract surgery, the laser pretreatment is associated with breakdown of blood-aqueous barrier (BAB) associated with increased aqueous total prostaglandin, cytokines and Oxygen-free radicals concentration. The prostaglandin rise immediately after laser pretreatment is further thought to be the causative factor for the intraoperative miosis in femtosecond laser-assisted cataract surgery. However, the analysis of anterior chamber inflammatory factors, oxidative stress, and pupil size after femtosecond laser-assisted cataract surgery between different laser platforms has not been investigated in clinical studies. Understanding the cytokine and chemokine changes related to the laser pretreatment provides better insight into the inflammatory response in femtosecond laser-assisted cataract surgery.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LenSx | Experimental | Device: LenSx |
| Z8 | Placebo comparator | Device: Z8 |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age related cataracts over 50 years old, nuclear grades II-III
Key exclusion criteria (2 listed)
- Eye diseases: glaucoma, uveitis
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 |
|---|---|---|
| LenSxThe patients in Group 1 conduct FLACS under LenSx | Device | LenSx |
| Z8The patients in Group 1 conducted FLACS using Z8 | Device | Z8 |
Primary outcome
PGE2
Time frame: through study completion, an average of half a year
The concentrations of PGE2 in aqueous humor
cytokines (IL-1β、IL-6, IL-8、TNF-a)
Time frame: through study completion, an average of half a year
The concentrations of cytokines (IL-1β、IL-6, IL-8、TNF-a) in aqueous humor
MDA
Time frame: through study completion, an average of half a year
The concentrations of MDA in aqueous humor
2 secondary outcomes
central corneal thickness
Time frame: through study completion, an average of half a year
central macular thickness
Time frame: through study completion, an average of half a year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LenSx and Z8 in people with Cataract, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 21 Oct 2024. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
PGE2 (time frame: through study completion, an average of half a year). 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 21 Oct 2024.