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NCT Number: NCT06754358

Clinical Application Comparison of Two Femtosecond Laser Systems

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

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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;
  • preoperative flare of more than 15ph/ms11, ECD<2000cells/mm2 or any other corneal pathologies;
  • coexisting serious ocular diseases including uveitis, uncontrolled glaucoma, optic atrophy , amblyopia, retinopathies, or inflammatory pathology of the eye;
  • history of intraocular trauma, surgery, or retinal laser procedures;
  • usage of systemic or topical steroids or NSAIDs within one month prior to surgery;
  • patients with diabetes or any other systemic diseases that might confound the results or increase the risk for postoperative inflammation;
  • intraoperative complications such as capsule tear, hyphema, vitreous loss, iris manipulation, or miosis after laser pre treatment requiring intracameral injection of epinephrine;
  • 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;
  • potentially pregnant women;
  • 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.

Treatment and study plan

LenSx

Procedure

Participants undergo FLACS using LenSx femtosecond laser system

Z8

Procedure

Participants undergo FLACS using Z8 femtosecond laser system

Primary outcomes

  1. ocular staining score

    Time frame: 1 month after operation

    The ocular staining score ranged from 0 to 12. A score of 0 indicated no corneal or conjunctival staining with fluorescein or lissamine green dye, respectively. A score of 12 indicated severe staining of the cornea and conjunctiva with confluent and central fluorescein staining, the presence of corneal filaments, and confluent areas of lissamine green of the bulbar conjunctiva of greater than or equal to 4 mm2.

Secondary outcomes

  1. ocular staining score

    Time frame: 1 day and 1 week after operation

    The ocular staining score ranged from 0 to 12. A score of 0 indicated no corneal or conjunctival staining with fluorescein or lissamine green dye, respectively. A score of 12 indicated severe staining of the cornea and conjunctiva with confluent and central fluorescein staining, the presence of corneal filaments, and confluent areas of lissamine green of the bulbar conjunctiva of greater than or equal to 4 mm2.

  2. phacoemulsification time

    Time frame: in the operation

  3. ultrasound power

    Time frame: in the operation

  4. vacuum docking time

    Time frame: in the operation

  5. femtosecond laser emission time

    Time frame: in the operation

  6. femtosecond laser-assisted capsulorhexis time

    Time frame: in the operation

  7. femtosecond laser-assisted pre-chop time

    Time frame: in the operation

  8. surgical time

    Time frame: in the operation

  9. surgical complication

    Time frame: in the operation

  10. DEQ-5 questionnaire

    Time frame: 1 week and 1 month after the operation

    The dry-eye questionnaire-5 (DEQ-5) is a validated questionnaire that has been shown to discriminate between different severities of dry eye. Participants self-assessed the frequency and severity of eye discomfort, eye dryness, and watery eyes experienced during the evening of a typical day within the last month. Responses were given using a Likert scale with scoring criteria from 0 = never experienced the symptom to 5 = extremely severe experience of symptom. The sum of the scores from the five questions was used in the analysis.

  11. OSDI questionnaire

    Time frame: 1 week and 1 month after the operation

    Ocular surface disease index (OSDI) is a widely accepted questionnaire on subjective symptoms in patients with dry eyes. It consisted of 12 questions on eye-related symptoms, vision-related function, and environment-related symptoms. Each question is evaluated according to the frequency of occurrence: never, 0 point; occasionally, 1 point; often, 2 points; most of the time, 3 points; all the time, 4 points. Not all the 12 questions needed to be answered. If the question is that the patient didn't participate in the activity or the environment that would not be in the case, it would not be answered and scored. The final score is calculated according to the formula: OSDI values=(sum of all survey items)×100/(answered survey items)×4.

  12. tear meniscus height

    Time frame: 1 day, 1 week, and 1 month after the operation

    The tear meniscus assessment height was measured with the Ocular Surface Analyser (SBM Sistemi, Orbassano, Italy)

  13. noninvasive tear film breakup time

    Time frame: 1 day, 1 week, and 1 month after the operation

    Noninvasive tear film breakup time was assessed automatically using the Ocular Surface Analyser (SBM Sistemi, Orbassano, Italy). The participants were instructed to blink naturally two times and then to cease blinking until instructed to blink again. Three measurements were performed for each eye and the average for each eye included for analysis.

  14. tear-film assessment

    Time frame: 1 day, 1 week, and 1 month after the operation

    The tear-film assessment was assessed with the Ocular Surface Analyser (SBM Sistemi, Orbassano, Italy).

  15. Schirmer I test

    Time frame: 1 day, 1 week, and 1 month after the operation

    The Schirmer I test was carried out under natural light. A 5 mm×35 mm Schirmer test strip was placed in the middle and outer 1/3 junction of the lower conjunctival sac of the affected eye without anesthesia. The patient was asked to close eyes gently. After 5min, the strip was removed and the wet length of the strip was measured. Values less than 5 mm are indicators for dry eye syndrome.

  16. visual acuity

    Time frame: 1 day, 1 week, and 1 month after the operation

  17. intraocular pressure

    Time frame: 1 day, 1 week, and 1 month after the operation

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Comparison of Perioperative Parameters of Femtosecond Laser-assisted Cataract Surgery Using Two Laser Systems: a Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 31, 2024
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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