Contact information
Type
Scientific
Primary contact
Dr Albrecht Hennig
ORCID ID
Contact details
Sagarmatha Choudhary Eye Hospital
G.P.O. Box 15108
Kathmandu
Lahan
-
Nepal
+977 (0)33 560 402
albrecht.hennig@erec-p.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Randomised controlled trial comparing the effectiveness and cost of foldable and rigid intraocular lenses in phacoemulsification cataract surgery in Nepal
Acronym
Study hypothesis
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
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)
Study design
Randomised interventional single-centre study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
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 trial start date
25/09/2010
Overall trial end date
24/09/2012
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with cataract, aged 35 to 70 years, either sex
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1200
Participant 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
Recruitment start date
25/09/2010
Recruitment end date
24/09/2012
Locations
Countries of recruitment
Nepal
Trial participating centre
Sagarmatha Choudhary Eye Hospital
Lahan
-
Nepal
Sponsor information
Organisation
Sagarmatha Choudhary Eye Hospital (Nepal)
Sponsor details
G.P.O.Box 15108
Kathmandu
Lahan
-
Nepal
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Sagarmatha Choudhary Eye Hospital (Nepal)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
CBM eV (Germany)
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
Basic results (scientific)
Publication list