Comparison of Clinical Outcomes in Ziemer Femtosecond Versus Conventional Phacoemulsification Surgery

NCT03351894 | Completed DMC

• 1 other identifier: SERI R1249/55/2015
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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

Conditions

Visual Outcomes

Outcome Measures

Primary Outcomes (1)

• Cumulative dissipated energy (CDE)

  Energy from phaco machine

  12 months

Secondary Outcomes (8)

• Best corrected distance visual acuity (snellen)

  12 months

• Refraction (diopters)

  12 months

• Corneal endothelial count

  12 months

• Anterior chamber inflammation (by flaremeter)

  12 months

• Effective intraocular lens position (UBM)

  12 months

Study Arms (2)

Conventional

PLACEBO COMPARATOR

Conventional phacoemulsification surgery

Procedure: Conventional phacoemulsification

Femtosecond laser

ACTIVE COMPARATOR

Ziemer femtosecond laser assisted cataract surgery Intervention: Ziemer femtosecond laser assisted cataract surgery

Procedure: Femtosecond laser assisted cataract surgery

Interventions

Femtosecond laser assisted cataract surgery PROCEDURE

Ziemer Z8 femtosecond laser assisted cataract surgery

Femtosecond laser

Conventional phacoemulsification PROCEDURE

conventional phacoemulsification with infinity phaco

Conventional

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Singapore Eye Research Institute: lead

Study Sites (1)

Singapore Eye Research Institute

Singapore, 169856, Singapore

Location

Study Officials

• Jodhbir Mehta

  Singapore National Eye Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior consultant

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: November 24, 2017
• Study Start: August 1, 2015
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

SG (1)