Status:
COMPLETED
Comparison of Clinical Outcomes in Ziemer Femtosecond Versus Conventional Phacoemulsification Surgery
Lead Sponsor:
Singapore Eye Research Institute
Conditions:
Visual Outcomes
Eligibility:
All Genders
55+ years
Phase:
NA
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-inf...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2024
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT03351894
Start Date
August 1 2015
End Date
February 28 2024
Last Update
May 29 2025
Active Locations (1)
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1
Singapore Eye Research Institute
Singapore, Singapore, 169856