Comparison of Clinical Outcomes in Ziemer Femtosecond Versus Conventional Phacoemulsification Surgery

Comparison of Clinical Outcomes in Ziemer LDV Z8 Femtosecond Laser-assisted Cataract Surgery

This study is aimed to compare the clinical outcomes in Ziemer LDV Z8 femtosecond laser-assisted cataract surgery versus conventional phacoemulsification cataract surgery

Study Overview

• Status: Completed
• Conditions: Visual Outcomes
• Intervention / Treatment: Procedure: Conventional phacoemulsification; Procedure: Femtosecond laser assisted 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 Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169856
    • Singapore Eye Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Conventional; Conventional phacoemulsification surgery	Procedure: Conventional phacoemulsification; conventional phacoemulsification with infinity phaco
Active Comparator: Femtosecond laser; Ziemer femtosecond laser assisted cataract surgery Intervention: Ziemer femtosecond laser assisted cataract surgery	Procedure: Femtosecond laser assisted cataract surgery; Ziemer Z8 femtosecond laser assisted cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative dissipated energy (CDE)	Energy from phaco machine	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Singapore Eye Research Institute
• Investigators: Principal Investigator: Jodhbir Mehta, Singapore National Eye Centre

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): February 28, 2024
• Study Completion (Actual): February 28, 2024

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: November 19, 2017
• First Posted (Actual): November 24, 2017

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: SERI R1249/55/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED