Addressing of Efficacy and Safety of Femtosecond-laser Assisted Versus Manual Lens Fragmentation Procedure

NCT01971177 | Completed Phase 4

• 1 other identifier: 1304
• Study Type: interventional
• Target: 136
• Locations: 2 countries
• Sites: 2

Brief Summary

This clinical study is a randomized, controlled, open, prospective, multi-centre, multi-surgeon post-market-clinical-follow-up study to investigate the impact of cataract grade on the efficacy and safety of femtosecond laser assisted lens fragmentation to support phacoemulsification of the cataractous lens prior to intraocular lens (IOL) implantation.

Conditions

Cataract

Outcome Measures

Primary Outcomes (1)

• Effective Phacoemulsification Time

  The effective phacoemulsification time (EPT) used the "Laser group" (pooled from all grades) during phacoemulsification is lower than or equal to that in the "Manual group" (pooled from all grades); p\<0.05 will be considered statistically significant.

  This criterion should be achieved at the day of treatment.

Secondary Outcomes (1)

• Adverse Events

  This purpose criterion should be achieved intraoperative, at 1 day, 1 week and 1 month.

Study Arms (2)

Femtosecond laser cataract surgery

EXPERIMENTAL

"Laser group": a pre-fragmentation of the ocular lens will be performed by VICTUS femtosecond laser lens fragmentation procedure.

Device: Femtosecond laser cataract surgery

Manual cataract surgery

ACTIVE COMPARATOR

"Manual": manual group acts as a control group where the lens fragmentation are performed manually without femtosecond laser assisted lens fragmentation

Procedure: Manual cataract surgery

Interventions

Femtosecond laser cataract surgery DEVICE

The VICTUS lens fragmentation procedure is part of the femtosecond laser assisted cataract procedure, which generates precise cuts inside the cataractous lens, leading to a softening and fragmentation of the lens. The correct positioning of the cuts inside the lens can be verified by means of an optical coherence tomograph (OCT) before starting the laser assisted fragmentation process. Various surgical patterns will be used within this study. For each pattern different geometry/laser parameters can be adjusted individually according to each patient's cataract status. All the patients who are enrolled in the laser groups (all cataract grades) will be treated with femtosecond laser assisted capsulotomy before the femtosecond laser assisted lens fragmentation by VICTUS femtosecond laser platform.

Femtosecond laser cataract surgery

Manual cataract surgery PROCEDURE

"Manual": manual group acts as a control group where the lens fragmentation are per-formed manually without femtosecond laser assisted lens fragmentation

Manual cataract surgery

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have read, understood and signed the Patient Information
• Patients are willing and able to return for follow-up examinations
• Clear corneal media
• Cataract grade (nuclear) from I to V according to LOCS III
• Patients must be at least 40 years of age

You may not qualify if:

• Patients presenting a clear lens (clear lens exchange)
• Glaucoma and suspected glaucoma
• Patients with pre-existing proliferative diabetic retinopathy (mild and tight controlled diabetes symptoms, without retinopathy and non-proliferative diabetic retinopathy, can be included.)
• Retinal disorders
• Rheumatic diseases
• Occlusion of retinal vessels
• Pellucid marginal degeneration
• Herpes zoster or herpes simplex keratitis
• Heavy vascularization of the ocular tissue
• Epilepsy
• Recurrent corneal erosion
• Severe basement membrane disease
• Patients who suffer from severe wound-healing disorders such as connective tissue disease, autoimmune illnesses, immunodeficiency illnesses,endocrine diseases, lupus, rheumatoid arthritis, collagenosis, or clinically significant atopy
• Patients suffering from AIDS or HIV.
• Chemosis

Sponsors & Collaborators

• Technolas Perfect Vision GmbH: lead

Study Sites (2)

Gemini Eye Clinic

Zlín, 76001, Czechia

Location

MaxiVision Laser Centre Private Limited

Hyderabad, 500082, India

Location

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Pavel Stodulka, Dr. med

  Gemini clinic, Zlin, Czech Republic 76001

  PRINCIPAL INVESTIGATOR

• Kasu Prasad Reddy, MD

  MaxiVision Laser Centre Private Limited, Hyderabad, India

  PRINCIPAL INVESTIGATOR

• N Sreelakshmi, MD

  MaxiVision Laser Centre Private Limited, Hyderabad, India

  PRINCIPAL INVESTIGATOR

• Stephen Slade, MD

  Slade & Baker Vision Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2013
• First Posted: October 29, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 14, 2014

Record last verified: 2014-03

Locations

IN (1); CZ (1)