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 |
| Protocol serial number | N/A |
| Sponsor | The Medical University of Vienna (Austria) |
| Funder | The Medical University of Vienna (Austria) - internally funded |
- 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
Scientific
Department of Ophthalmology
Medical University of Vienna
Waehringer Guertel 18-20
Vienna
A -1090
Austria
| Phone | +43 (0)1 40400 7940 |
|---|---|
| rupert.menapace@meduniwien.ac.at |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, randomised, single-masked clinical trial with within-patient comparison. |
| Secondary study design | Randomised controlled trial |
| Scientific title | 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 |
| Study objectives | 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(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) studied | 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 |
| Primary outcome measure(s) |
The following measurements will be performed preoperatively, at 1 day, 1 week, 1 month, and 8 - 12 months postoperatively: |
| Key secondary outcome measure(s) |
No secondary outcome measures |
| Completion date | 01/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 50 |
| Key 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 |
| Key exclusion criteria | 1. Anamnesis or clinical signs of uveitis 2. Glaucoma 3. Proliferative diabetic retinopathy 4. Trauma 5. Small pupil 6. Previous ophthalmic operation |
| Date of first enrolment | 20/08/2007 |
| Date of final enrolment | 01/12/2007 |
Locations
Countries of recruitment
- Austria
Study participating centre
Department of Ophthalmology
Vienna
A -1090
Austria
A -1090
Austria
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
