Contact information
Type
Scientific
Primary contact
Prof Rupert Menapace
ORCID ID
Contact details
Department of Ophthalmology
Medical University of Vienna
Waehringer Guertel 18-20
Vienna
A -1090
Austria
+43 (0)1 40400 7940
rupert.menapace@meduniwien.ac.at
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
A Primary Posterior Continuous Curvilinear Capsulorhexis (PPCCC) is the method of removing the central part or the posterior capsule during cataract surgery to prevent the formation of Posterior Capsule Opacification (PCO). One way to prevent lens epithelial cell growing on an intact vitreous face is using a buttonhole technique (Posterior Buttonholing [POBH]) to place the optic of the Intraocular Lens (IOL) posteriorly through the PCCC.
These recent improvements in surgical technique have reduced or delayed the incidence of PCO formation in adults. These new techniques could be a welcome addition to other attempts of preventing PCO. Therefore it is the aim of the present studies to compare the influence of PCCC, POBH and conventional in-the-bag implantation of IOL on PCO, visual acuity, and the axial IOL shift.
Ethics approval
The Ethics Committee of the Medical University of Vienna (Borschkegasse 8b/E 06, A-1090 Vienna, Austria) approved this study on the 13th March 2007 (ref: 067/2007).
Study design
Prospective, randomised, single-masked clinical trial with within-patient comparison.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Cataract surgery innovation
Intervention
Cataract surgery will be performed under topical anaesthesia through a 3.0 mm temporal self-sealing sclero-corneal tunnel incision. In all techniques, the Anterior Continuous Curvilinear Capsulorhexis (ACCC) with appropriate overlap of the IOL optic will be created using a needle. Thereafter hydrodissection, phacoemulsification and irrigation/aspiration of the lens will be performed.
In randomised order, cataract surgery with combined PPCCC and POBH will be performed in one eye; in the fellow eye cataract surgery will be performed conventionally with in-the-bag IOL implantation keeping the posterior lens capsule intact (standard procedure).
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
The following measurements will be performed preoperatively, at 1 day, 1 week, 1 month, and 8 - 12 months postoperatively:
1. Anterior and posterior capsule opacification
2. Intraocular lens position
3. Best corrected visual acuity
4. Contrast sensitivity
5. Optical Coherence Tomography (OCT) central retinal thickness
6. Postoperative vitreous detachment
Secondary outcome measures
No secondary outcome measures
Overall trial start date
20/08/2007
Overall trial end date
01/12/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Patients with age-related cataract on both eyes awaiting bilateral same-day cataract surgery
2. Age range: 55 - 88 years, both male and female
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60 patients (120 eyes)
Participant exclusion criteria
1. Anamnesis or clinical signs of uveitis
2. Glaucoma
3. Proliferative diabetic retinopathy
4. Trauma
5. Small pupil
6. Previous ophthalmic operation
Recruitment start date
20/08/2007
Recruitment end date
01/12/2007
Locations
Countries of recruitment
Austria
Trial participating centre
Department of Ophthalmology
Vienna
A -1090
Austria
Sponsor information
Organisation
The Medical University of Vienna (Austria)
Sponsor details
Waehringer Guertel 18-20
Vienna
A -1090
Austria
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
The Medical University of Vienna (Austria) - internally funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list