Condition category
Surgery
Date applied
17/08/2007
Date assigned
26/10/2007
Last edited
05/11/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.meduniwien.ac.at/index.php?id=372&language=2

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes