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Comparison of postoperative parameters in cataract surgery with two different fluidic settings

Comparison of phacoemulsification cataract surgery with low versus standard fluidic sttings and the impact on postoperative parameters

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11821734
Enrollment
43
Registered
2016-01-20
Start date
2012-09-26
Completion date
Unknown
Last updated
2016-10-17

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

Conditions

Postoperative complications in cataract surgery Eye Diseases Postoperative complications in cataract surgery

Interventions

Participants will be randomised to receive either low- or standard fluidic settings. They will all be implanted with an AcrySof SN60WF intraocular lens (IOL). Perioperatively the saline bag will be w

Sponsors

Eye Foundation (Ögonfonden)
Lead Sponsor
Stockholm County Council
Collaborator
Karolinska Institute
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged between 55 and 85 2. Presence of senile cataract

Exclusion criteria

Exclusion criteria: 1. Traumatic cataract 2. Extremely dense cataract 3. Subluxated lens 4. Macular or corneal disease 5. Anterior chamber depth shallower than 2.1 mm 6. Pupil dilated less than 5 mm in diameter with 0.2 ml solution of cyclopentolate 0.1% and phenylephrine 1.5% 7. Diabetes 8. Glaucoma 9. Continuous treatment with oral or nasal nonsteroidal anti-inflammatory drugs or steroids Previous intraocular surgery or retinal photocoagulation

Design outcomes

Primary

MeasureTime frame
1. Duration of surgery is measured during surgery in minutes 2. Consumed balanced saline solution is determined by weighing the saline bag before and after surgery. The saline for hydrodissection and wetting of the cornea is withdrawn before the baseline measurement. 3. Cumulative dissipated energy is determined by recording the CDE-value from the LCD display of the Phacoemulsification machine 4. Central corneal thickness is measured with Anterior segment OCT at baseline, 1 day, 3 weeks and 3 months 5. Endothelial cell density is measured using confocal microscopy at baseline and 3 months 6. Anterior chamber flare is measured by laser flare meter at baseline, 1 day, and 3 weeks 7. Macular thickness is measured by OCT at baseline, 1 day, 3 weeks and 3 months

Secondary

MeasureTime frame
1. Intraocular pressure is measured using Goldmann applanation tonometry at baseline, 1 day, 3 weeks and 3 months 2. Corrected distance visual acuity is measured using a ETDRS chart during ophthalmologic examinations at baseline, 1 day, 3 weeks and 3 months

Countries

Sweden

Outcome results

None listed

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