A Single Centre Study to Analyze Cataract Surgery Following Femtosecond Laser-Assisted and Manual Cataract Surgery

Technolas Perfect Vision

Status and phase

Completed

Phase 4

Conditions

Cataract

Treatments

Device: Laser-assisted cataract surgery

Device: Manually performed cataract surgery

Study type

Interventional

Funder types

Industry

Identifiers

NCT01769313

1202

Details and patient eligibility

About

This clinical study (non AMG/non MPG) is a contralateral, comparative, randomized, prospective, single-center, multi-surgeon, investigator masked study to investigate whether the femtolaser cataract surgery causes any significant differences in the resulting Intra Ocular Lens overlap (ΔROverlap) as compared to the conventional, manual continuous curvilinear capsulorhexis (CCC). The Intra Ocular Lens overlap (ΔROverlap) is defined as the difference between the Intra Ocular Lens center of mass to the capsulotomy aperture center of mass.

Full description

A detailed pre-operative examination will ensure that every interested and willing patient fulfills the inclusion criteria of this study. For the proposed contralateral eye study between 30 and 35 patients will be enrolled whereas one eye will randomized undergo a manual cataract surgery and the other one a laser assisted cataract surgery. In total between 60 and 70 eyes will be included in the study. Pre-operative examinations are included to confirm to the clinical practice. Examinations on the day of surgery and any occurrence during the procedure are also listed. Post-operative examinations, which should document any occurrence, the outcome of and possible differences between the treatment techniques, are to be carried out after 1 day, 1 week, 1 month, 3 months and 6 months. After 6 month a final report including the study results will be produced.

The study is carried out in compliance with MEDDEV 2.7.1 Evaluation of Clinical Data: A Guide for Manufacturers and Notified Bodies, ICH E6 (R1) Good Clinical Practice (GCP), Declaration of Helsinki as well as the applicable local regulations such as notification requirements and current order of profession of the primary investigators.

Enrollment

30 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Clear corneal media
Patients must be at least 18 years of age
Patients must have read, understood and signed the Patient Information
Patients are willing and able to return for follow-up examinations
Topographic Astigmatism ≤ 1.5 dpt
Patient will get a monofocal IOL (Envista) implanted

Exclusion criteria

On a keratometric map of the cornea, the minimal and maximal K-values of the central 3mm zone must not differ by more than 5D (exclusion criterium for Group A only)
The maximum K- value may not exceed 60D, the minimal value may not be smaller than 37D (exclusion criterium for Group A only)
Corneal disease or pathology, such as corneal scaring or opacity, that precludes transmission of laser wavelength or that distorts laser light (exclusion criteria for Group A only)
Subjects with a poorly dilating pupil or other defect of the pupil that prevents the iris from adequate retraction peripherally
Lens/zonular instability such as, but not restricted to, Marfan's Syndrome, Pseudoexfoliation Syndrome, etc.
Manifest Glaucoma
Patients presenting a clear lens (clear lens exchange)
Previous intraocular or corneal surgery of any kind, including any type of surgery for either refractive or therapeutic purposes in either eye
Known sensitivity to planned concomitant medications
Patients with disorders of the ocular muscle, such as nystagmus or strabismus
Patients with keratoconus or keratectasia
Patients with connective tissue weakness
Patients who are blind on one eye
Subjects who are immune compromised or carrying diagnosis of connective tissue disease, clinically significant atopic disease, insulin dependent diabetes mellitus, autoimmune diseases, ocular herpes zoster or simplex, endocrine diseases, lupus, rheumatoid arthritis, collagenosis and other acute or chronic illnesses that will increase the risk to the subject or confound the outcomes of this study.
Abnormal examination results from slit lamp, fundus examination or IOL Master, age related changes are acceptable
Abnormal examination results from Orbscan (exclusion criteria for Group A only; , age related changes are acceptable
Patients who are pregnant or nursing
Patients who do not give informed consent
Patients with concentration disorders, epilepsy and other complicating diseases
Patients regularly taking medicines that could influence the result of the treatment
Patients who are participating in another ophthalmological clinical study
Patients with an anterior chamber depth (ACD) < 1.5 mm or ACD > 4.8 mm as measured as from the corneal endothelium.