Comparison of Clinical Outcomes in Ziemer Femtosecond Versus Conventional Phacoemulsification Surgery

Not Applicable

• Conditions: Visual Outcomes
• Interventions: Procedure: Conventional phacoemulsification; Procedure: Femtosecond laser assisted cataract surgery

• Registration Number: NCT03351894
• Lead Sponsor: Singapore Eye Research Institute

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2017-11-19
• Study First Posted: 2017-11-24
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-25
• Primary Completion: 2020-08
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 95

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional	Conventional phacoemulsification	Conventional phacoemulsification surgery
Femtosecond laser	Femtosecond laser assisted cataract surgery	Ziemer femtosecond laser assisted cataract surgery Intervention: Ziemer femtosecond laser assisted cataract surgery

Primary Outcome Measures

Name	Time	Method
Cumulative dissipated energy (CDE)	12 months	Energy from phaco machine

Secondary Outcome Measures

Name	Time	Method
Refraction (diopters)	12 months	Sphere and cyl, manifest
Optic disc nerve(OCT)	12 months	RNFL
Anterior chamber inflammation (by flaremeter)	12 months	pixels
Intraocular pressure (mmHg)	12 months	mmHg
Patient surgery experiences (questionnaire)	12 months	Qualitative patient experience
Effective intraocular lens position (UBM)	12 months	lens tilt
Corneal endothelial count	12 months	cells/mm2
Best corrected distance visual acuity (snellen)	12 months	LogMar VA

Trial Locations

Locations (1)

Singapore Eye Research Institute; 🇸🇬 Singapore, Singapore