Cataract surgery with combined Primary Posterior Continuous Curvilinear Capsulorhexis (PPCCC) and Posterior Buttonholing (POBH) in comparison to conventional in the bag Intraocular Lens (IOL) implantation

ISRCTN ISRCTN35593439
DOI https://doi.org/10.1186/ISRCTN35593439
Secondary identifying numbers N/A
Submission date
17/08/2007
Registration date
26/10/2007
Last edited
31/12/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Rupert Menapace
Scientific

Department of Ophthalmology
Medical University of Vienna
Waehringer Guertel 18-20
Vienna
A -1090
Austria

Phone +43 (0)1 40400 7940
Email rupert.menapace@meduniwien.ac.at

Study information

Study designProspective, randomised, single-masked clinical trial with within-patient comparison.
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleCataract surgery with combined Primary Posterior Continuous Curvilinear Capsulorhexis (PPCCC) and Posterior Buttonholing (POBH) in comparison to conventional in the bag Intraocular Lens (IOL) implantation
Study objectivesA 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(s)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).
Health condition(s) or problem(s) studiedCataract surgery innovation
InterventionCataract 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 typeProcedure/Surgery
Primary outcome measureThe 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 measuresNo secondary outcome measures
Overall study start date20/08/2007
Completion date01/12/2007

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants60 patients (120 eyes)
Total final enrolment50
Key inclusion criteria1. Patients with age-related cataract on both eyes awaiting bilateral same-day cataract surgery
2. Age range: 55 - 88 years, both male and female
Key exclusion criteria1. Anamnesis or clinical signs of uveitis
2. Glaucoma
3. Proliferative diabetic retinopathy
4. Trauma
5. Small pupil
6. Previous ophthalmic operation
Date of first enrolment20/08/2007
Date of final enrolment01/12/2007

Locations

Countries of recruitment

  • Austria

Study participating centre

Department of Ophthalmology
Vienna
A -1090
Austria

Sponsor information

The Medical University of Vienna (Austria)
University/education

Waehringer Guertel 18-20
Vienna
A -1090
Austria

Website http://www.meduniwien.ac.at/index.php?id=372&language=2
ROR logo "ROR" https://ror.org/05n3x4p02

Funders

Funder type

University/education

The Medical University of Vienna (Austria) - internally funded

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article intraocular pressure results 01/11/2010 31/12/2020 Yes No
Results article macular morphology results 01/07/2008 31/12/2020 Yes No

Editorial Notes

31/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.