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Foldable versus rigid intraocular lenses in phacoemulsification cataract surgery in Nepal

Randomised controlled trial comparing the effectiveness and cost of foldable and rigid intraocular lenses in phacoemulsification cataract surgery in Nepal

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN63984643
Enrollment
1200
Registered
2011-02-09
Start date
2010-09-25
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract surgery (phacoemulsification) Eye Diseases Cataract surgery

Interventions

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 Simc
follow-up is 12 months.

Sponsors

Sagarmatha Choudhary Eye Hospital (Nepal)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients with cataract, aged 35 to 70 years, either sex

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Nepal

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026