Effect of a plate haptic design on intraocular lens rotational-and-axial stability and posterior capsule opacification: a randomised trial (acrismart versus acrilyc intraocular lenses)
| ISRCTN | ISRCTN01285948 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN01285948 |
| Protocol serial number | FINO1002 |
| Sponsor | Moorfields Eye Hospital NHS Foundation Trust (UK) |
| Funder | Acri.tec AG (Germany) |
- Submission date
- 12/12/2006
- Registration date
- 29/01/2007
- Last edited
- 29/06/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Oliver Findl
Scientific
Scientific
Moorfields Eye Hospital NHS Foundation Trust
162 City Road
London
EC1V 2PD
United Kingdom
| Phone | +44 (0)20 7566 2036 |
|---|---|
| oliver.findl@moorfields.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, bilateral, double-masked clinical trial with intra-individual comparison at two centres (Moorfields Eye Hospital [MEH] and Vienna) |
| Secondary study design | Randomised controlled trial |
| Scientific title | Effect of a plate haptic design on IntraOcular Lens rotational-and-axial stability and posterior capsule opacification: a randomised trial (Acrismart versus Acrilyc IntraOcular Lenses) |
| Study objectives | Is the evaluation of the rotational stability (of importance for toric models), the axial stability (of importance regarding postoperative refractive outcome and refractive surprises) and the development of posterior capsular opacification of a modern MicroIncision Cataract Surgery (MICS)-compatible single-piece IntraOcular Lens (IOL) (Acri.Smart 46S) which is CE-marked and commercially available (since 2004) compared to that of an open-loop three-piece model made of the same optic material (AcriLyc 53N). Both IOL models have sharp optic edges. |
| Ethics approval(s) | Moorfields and Whittington LREC on the 15th November 2006 (ref: 06/Q0504/97). |
| Health condition(s) or problem(s) studied | Cataract; posterior capsular opacification |
| Intervention | Intraocular lens implant (Acrismart or Acrylic lens) |
| Intervention type | Other |
| Primary outcome measure(s) |
Posterior capsule opacification (%) |
| Key secondary outcome measure(s) |
1. Orientation (degrees) |
| Completion date | 28/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 25 |
| Key inclusion criteria | 1. Bilateral age-related cataract 2. Age 40 and older 3. Visual Acuity more than 0.05 4. Written informed consent to surgery and participation in the study |
| Key exclusion criteria | Relevant other ophthalmic diseases (such as pseudoexfoliation, glaucoma, traumatic cataract and other comorbidity that could affect Posterior Capsule Opacification (PCO) rate, axial and rotational stability (e.g. Marfan syndrome) |
| Date of first enrolment | 28/11/2006 |
| Date of final enrolment | 28/05/2010 |
Locations
Countries of recruitment
- United Kingdom
- England
- Austria
Study participating centre
Moorfields Eye Hospital NHS Foundation Trust
London
EC1V 2PD
United Kingdom
EC1V 2PD
United Kingdom
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 | results: | 01/12/2013 | Yes | No |
Editorial Notes
29/06/2016: Publication reference added
