Condition category
Eye Diseases
Date applied
29/10/2010
Date assigned
09/02/2011
Last edited
15/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.erec-p.org

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes