Foldable versus rigid intraocular lenses in phacoemulsification cataract surgery in Nepal

ISRCTN	ISRCTN63984643
DOI	https://doi.org/10.1186/ISRCTN63984643
Secondary identifying numbers	N/A

Submission date: 29/10/2010
Registration date: 09/02/2011
Last edited: 15/02/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Eye Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Albrecht Hennig
Scientific

Sagarmatha Choudhary Eye Hospital
G.P.O. Box 15108
Kathmandu
Lahan
-
Nepal

Phone	+977 (0)33 560 402
Email	albrecht.hennig@erec-p.org

Study information

Study design	Randomised interventional single-centre study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Randomised controlled trial comparing the effectiveness and cost of foldable and rigid intraocular lenses in phacoemulsification cataract surgery in Nepal
Study objectives	The main aim of the trial is to compare the outcome of foldable and rigid intraocular lenses (IOLs) in phacoemulsification cataract surgery. There is no significant difference in the visual outcome of phacoemulisfication using either a rigid polymethylacrylate posterior chamber intraocular lens (PMMA PC IOL) or a foldable PC IOL.
Ethics approval(s)	1. London School of Hygiene and Tropical Medicine (LSHTM) approved on the 22nd July 2010 (ref: 5714) 2. Nepal Netra Jyoti Sangh (NNJS), Institutional Research Review Board, Kathmandu/NEPAL, approved on the 27th August 2010 (ref: 52-067-068)
Health condition(s) or problem(s) studied	Cataract surgery (phacoemulsification)
Intervention	In both treatment groups, the cataract will be removed by phacoemulsification, using phaco chop technique (phaco machines: OS-3 OERTLI, Megatron GEUDER). The remaining cortex will be removed with Simcoe cannula and/or bimanual irrigation/aspiration system. In the "foldable" group, the intraocular lens (hydrophilic acrylic, IOCare, India) will be inserted with an injector through the 2.5 mm corneal incision and placed in the capsular bag. In the "rigid" group, the sclero-corneal incision will be enlarged to 5 mm and a 5 mm optic PMMA IOL (IOCare, India) will be inserted into the capsular bag. The surgery will be performed by two surgeons, both of whom are experienced in using both types of lenses. Treatment is a one-off procedure; follow-up is 12 months.
Intervention type	Other
Primary outcome measure	Visual acuity at one year after surgery in the operated eye: 1. Uncorrected visual acuity of 6/9 or more (i.e. very good functional vision) 2. Uncorrected visual acuity of 6/18 or more (i.e. operated eye is no longer "visually impaired" by World Health Organization [WHO] definitions) 3. Best corrected visual acuity worse than 6/60 (i.e. eye is effectively blind)
Secondary outcome measures	1. Visual acuity in the operated eye at other time points 2. Complications during surgery 3. Early post-operative complications 4. Long term complications 5. Astigmatism 6. Cost Measured at 6 weeks and 12 months.
Overall study start date	25/09/2010
Completion date	24/09/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	1200
Key inclusion criteria	Patients with cataract, aged 35 to 70 years, either sex
Key exclusion criteria	1. Corneal endothelial disease (Fuchs' dystrophy; corneal stromal scarring) 2. Intraocular pressure greater than 22 mmHg 3. A-Scan finding: less than 17.0 dpt, greater than 26.0 dpt 4. Any other eye disease except age related cataract 5. Very advanced hard lens nuclei, where phaco is not suitable (grade III+) 6. Diabetes mellitus
Date of first enrolment	25/09/2010
Date of final enrolment	24/09/2012

Locations

Countries of recruitment

Nepal

Study participating centre

Sagarmatha Choudhary Eye Hospital

Lahan
-
Nepal

Sponsor information

Sagarmatha Choudhary Eye Hospital (Nepal)
Hospital/treatment centre

G.P.O.Box 15108
Kathmandu
Lahan
-
Nepal

Website	http://www.erec-p.org

Funders

Funder type

Hospital/treatment centre

Sagarmatha Choudhary Eye Hospital (Nepal)

No information available

CBM eV (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan