Clinical trial NCT03351894: Comparison of Clinical Outcomes in Ziemer Femtosecond Versus Conventional Phacoemulsification Surgery
Official title: Comparison of Clinical Outcomes in Ziemer LDV Z8 Femtosecond Laser-assisted Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Outcomes
Lead sponsor: Singapore Eye Research Institute
Sponsor class: OTHER
First posted: 2017-11-24
Enrollment: 13
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

1. A cataract will be defined as clouding of the lens that interferes with normal vision.
2. Not relevant, as study not on cancer patients.
3. Only patients older than 50 years will be included, as cataracts develops with increasing age. No gender criteria are applied.
4. Only individuals with the mental capacity to provide informed consent with be included.

More specifically, all the following inclusion criteria must be met:

1. Patients have medically dilated pupil size of at least 4.0mm.
2. Patients are willing and able to sign a written Informed Consent Form prior to any study-specific procedures.
3. Patients are willing and able to return for scheduled follow-up examinations for 12 months after the cataract surgery.

Exclusion Criteria:

1. Patients with prior history of pseudoexfoliation syndrome.
2. Patients with a prior history of glaucoma filtration surgery.
3. Patients with optic atrophy.
4. 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..
5. Patients with a prior history of vitrectomy.
6. Patients with a prior history of cataract or refractive lens surgery
7. Patients with central corneal scarring.
8. Patients with residual, recurrent, active or uncontrolled eyelid disease.
9. Patients with significant corneal asymmetry or irregular topography.
10. Patients with anterior segment pathology.
11. Patients with any corneal abnormality
12. 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.
13. 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.
14. 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.

Primary outcomes:
measure: Cumulative dissipated energy (CDE)
timeFrame: 12 months
Secondary outcomes:
measure: Best corrected distance visual acuity (snellen)
timeFrame: 12 months
measure: Refraction (diopters)
timeFrame: 12 months
measure: Corneal endothelial count
timeFrame: 12 months
measure: Anterior chamber inflammation (by flaremeter)
timeFrame: 12 months
measure: Effective intraocular lens position (UBM)
timeFrame: 12 months
measure: Intraocular pressure (mmHg)
timeFrame: 12 months
measure: Patient surgery experiences (questionnaire)
timeFrame: 12 months
measure: Optic disc nerve(OCT)
timeFrame: 12 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Singapore Eye Research Institute
Study officials:
affiliation: Singapore National Eye Centre
name: Jodhbir Mehta
role: PRINCIPAL_INVESTIGATOR
References: