Clinical trial NCT06754358: Clinical Application Comparison of Two Femtosecond Laser Systems
Official title: Comparison of Perioperative Parameters of Femtosecond Laser-assisted Cataract Surgery Using Two Laser Systems: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Cataract
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-12-31
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the perioperative parameters of femtosecond laser-assisted cataract surgery (FLACS) using two laser systems.

Participants will:

Undergo FLACS using LenSx or Z8 femtosecond laser system Visit the clinic before the operation and 1 day, 1 week, and 1 month after the operation for checkups and tests Complete clinical measurements and dry eye questionnaires


Eligibility criteria: Inclusion Criteria:

1. Chinese Han patients aged 40 years or older
2. clinical diagnosis of age-related cataracts;
3. underwent FLACS with insertion of a posterior chamber IOL for the first eye.

Exclusion Criteria:

1. coexisting macular pathologies such as epiretinal membrane, macular hole or edema, or age-related macular degeneration. Patients with OCT scans of poor quality were excluded;
2. preoperative flare of more than 15ph/ms11, ECD\<2000cells/mm2 or any other corneal pathologies;
3. coexisting serious ocular diseases including uveitis, uncontrolled glaucoma, optic atrophy , amblyopia, retinopathies, or inflammatory pathology of the eye;
4. history of intraocular trauma, surgery, or retinal laser procedures;
5. usage of systemic or topical steroids or NSAIDs within one month prior to surgery;
6. patients with diabetes or any other systemic diseases that might confound the results or increase the risk for postoperative inflammation;
7. intraoperative complications such as capsule tear, hyphema, vitreous loss, iris manipulation, or miosis after laser pre treatment requiring intracameral injection of epinephrine;
8. ocular conditions contraindicating FLACS including poorly dilated pupils (\<5.0mm), narrow palpebral fissure, small hyperopic eyes with steep cornea (difficult to achieve suction), severe conjunctival chalasis, nystagmus, or lack of cooperation;
9. potentially pregnant women;
10. known sensitivity to concomitant medications used during perioperative period, participation in other clinical trial during the time of visit, or poor cooperation in diagnostic tests or non-compliance at follow-up.

Primary outcomes:
measure: ocular staining score
timeFrame: 1 month after operation
Secondary outcomes:
measure: ocular staining score
timeFrame: 1 day and 1 week after operation
measure: phacoemulsification time
timeFrame: in the operation
measure: ultrasound power
timeFrame: in the operation
measure: vacuum docking time
timeFrame: in the operation
measure: femtosecond laser emission time
timeFrame: in the operation
measure: femtosecond laser-assisted capsulorhexis time
timeFrame: in the operation
measure: femtosecond laser-assisted pre-chop time
timeFrame: in the operation
measure: surgical time
timeFrame: in the operation
measure: surgical complication
timeFrame: in the operation
measure: DEQ-5 questionnaire
timeFrame: 1 week and 1 month after the operation
measure: OSDI questionnaire
timeFrame: 1 week and 1 month after the operation
measure: tear meniscus height
timeFrame: 1 day, 1 week, and 1 month after the operation
measure: noninvasive tear film breakup time
timeFrame: 1 day, 1 week, and 1 month after the operation
measure: tear-film assessment
timeFrame: 1 day, 1 week, and 1 month after the operation
measure: Schirmer I test
timeFrame: 1 day, 1 week, and 1 month after the operation
measure: visual acuity
timeFrame: 1 day, 1 week, and 1 month after the operation
measure: intraocular pressure
timeFrame: 1 day, 1 week, and 1 month after the operation
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
Study officials:
References: