Completed

1118Prospective Evaluation of Circularity and Diameter of Femtosecond Laser Versus Manual Anterior Capsulotomy in Singapore National Eye Centre

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What is being tested

Femtosecond Laser (VICTUS™ Femtosecond Laser Platform)

+ Manual (CCC technique with Utrata forceps)

Device
Who is being recruted

Eye Diseases

+ Lens Diseases

+ Cataract

Over 18 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: September 2012
See protocol details

Summary

Principal SponsorTechnolas Perfect Vision GmbH
Last updated: July 1, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2012

Actual date on which the first participant was enrolled.

This clinical study is a controlled, open, randomized, prospective, single-centre, single-surgeon eye study to determine the precision of intraocular cuts for anterior capsulotomy in connection to cataract surgery and IOL implantation. The cuts are applied by means of the VICTUS femtosecond laser system using a cylindrical cut pattern with diameter and height dependent on anterior chamber depth, pupil diameter and ocular lens size for Group A and the manual surgery technique for Group B. The allocation of the surgery technique will be randomized between the study patient. Each surgery technique represents a study group. In Group A the anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery. Group B acts as a control group where the capsulotomy as well as the lens fragmentation is performed manually. The hypothesis of the study is that by means of intraocular, laser-induced cuts, circularity of the capsulotomy can be improved in a safe and effective way. A detailed pre-operative examination will ensure that every interested and willing patient fulfils the inclusion criteria of this study. Post-operative examinations, which should document the success of the treatment, are to be carried out after 1-day, 1-week, 1-month.

NCT01693211
Principal SponsorTechnolas Perfect Vision GmbH
Last updated: July 1, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

48 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Eye DiseasesLens DiseasesCataract

Criteria

3 inclusion criteria required to participate
Clear cornea media
Consenting patients undergoing phacoemulsification and IOL implant surgery for cataract, the diagnosis of which has been confirmed by another investigator
Pupil must be able to dilate to at least 6mm in diameter measured with the pupil gauge
7 exclusion criteria prevent from participating
ACD < 1.8 mm or ACD > 4.5 mm
Corneal disease or pathology that precludes transmission of laser wavelength or distortion of laser light
Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc
Patients with disorders of the ocular muscle, such as nystagmus or strabismus Keratoconus
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Capsulorhexis and pre-fragmentation of the nucleus are performed by the femtosecond laser.

Group II

Active Comparator
The Capulorhexis and nuclear fragmentation are performed manually.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Singapore National Eye Centre

Singapore, SingaporeOpen Singapore National Eye Centre in Google Maps
CompletedOne Study Center