Comparison of Clinical Outcomes in Ziemer Femtosecond Versus Conventional Phacoemulsification Surgery

• Sponsor: Singapore Eye Research Institute (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03351894
• Collaborator: (none)
• Enrollment: 95
• Location: 1
• Arms: 2
• Duration (Months): 69
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Visual Outcomes	Procedure: Femtosecond laser assisted cataract surgery; Procedure: Conventional phacoemulsification	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 95 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparison of Clinical Outcomes in Ziemer LDV Z8 Femtosecond Laser-assisted Cataract Surgery
• Study Start Date: Aug 1, 2015
• Anticipated Primary Completion Date: Aug 1, 2020
• Anticipated Study Completion Date: May 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Cumulative dissipated energy (CDE) [12 months]

   Energy from phaco machine

Secondary Outcome Measures

1. Best corrected distance visual acuity (snellen) [12 months]

   LogMar VA

2. Refraction (diopters) [12 months]

   Sphere and cyl, manifest

3. Corneal endothelial count [12 months]

   cells/mm2

4. Anterior chamber inflammation (by flaremeter) [12 months]

   pixels

5. Effective intraocular lens position (UBM) [12 months]

   lens tilt

6. Intraocular pressure (mmHg) [12 months]

   mmHg

7. Patient surgery experiences (questionnaire) [12 months]

   Qualitative patient experience

8. Optic disc nerve(OCT) [12 months]

   RNFL

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Singapore Eye Research Institute	Singapore		Singapore	169856

Sponsors and Collaborators

• Singapore Eye Research Institute

Investigators

• Principal Investigator: Jodhbir Mehta, Singapore National Eye Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jodhbir Mehta, Senior consultant, Singapore Eye Research Institute
• ClinicalTrials.gov Identifier: NCT03351894
• Other Study ID Numbers: SERI R1249/55/2015
• First Posted: Nov 24, 2017
• Last Update Posted: Mar 25, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided

Study Results

No Results Posted as of Mar 25, 2020