Comparison of two cataract surgery techniques: conventional phacoemulsification vs femtosecond laser-assisted cataract surgery

Cataract surgery prospective comparative clinical trial: femtosecond laser assisted cataract surgery vs conventional phacoemulsification

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14007865

Enrollment

100

Registered

2017-03-13

Start date

2013-10-28

Completion date

Unknown

Last updated

2019-03-04

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

Conditions

Cataract Eye Diseases Cataract

Interventions

Following provision of informed consent, participants eyes are randomised to receive conventional phacoemulsification or femtosecond laser-assisted cataract surgery on one of their eyes, and receive t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients of over 50 years of age 2. Healthy eyes with cataract 3. IOL implantation in capsular bag with injector 4. Signed informed consent 5. Follow-up exam assistance assured

Exclusion criteria

Exclusion criteria: 1. Pseudophakia 2. Cornea guttata; corneal degeneration 3. Irregular astigmatism; keratoconus 4. Corneal scarring 5. Keratoplasty 6. Glaucoma 7. Intraocular inflammatory process and/or other preexistant events that could possibly permanently limit postoperative best corrected visual acuity 8. Amblyopia 9. Retinal detachment surgery 10. Any kind of macular degeneration or retinal alterations 11. Intraocular tumours 12. Capsular bag condition that contraindicates intraocular lens implantation 13. Intraoperative complications Complicaciones intraoperatorias 14. Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
1. Uncorrected distance visual acuity is measured using the logMAR scale pre-operatively, 1 day, 1 week, 1, 3 and 6 months after surgery 2. Best distance corrected visual acuity is measured using the logMAR scale pre-operatively, 1 week, 1, 3 and 6 months after surgery. 3. Objective optical quality is measured using the OQAS -Optical Quality Analysis System pre-operatively, 1 day, 1 week, 1, 3 and 6 months after surgery 4. Refraction is measured using an autorefractometer pre-operatively, 1 day, 1 week, 1, 3 and 6 months after surgery	—

Measure

Time frame

1. Uncorrected distance visual acuity is measured using the logMAR scale pre-operatively, 1 day, 1 week, 1, 3 and 6 months after surgery 2. Best distance corrected visual acuity is measured using the logMAR scale pre-operatively, 1 week, 1, 3 and 6 months after surgery. 3. Objective optical quality is measured using the OQAS -Optical Quality Analysis System pre-operatively, 1 day, 1 week, 1, 3 and 6 months after surgery 4. Refraction is measured using an autorefractometer pre-operatively, 1 day, 1 week, 1, 3 and 6 months after surgery

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Secondary

Measure	Time frame
1. Phacoemulsification is assessed using the inifinity phacoemulsification machine at the end of surgery at the surgical visit. 2. Endothelial cell quantitative and morphologic analysis is measured using a SP-3000 specular microscope pre-operatively, 1 day, 1 week, 1, 3 and 6 months after surgery 3. IOL position is assessed by measuring the torizontal tilt using a TMS-5 Scheimpflug Topographer 1 day, 1 week, 1, 3 and 6 months after surgery and IOL decentration using Adobe Photoshop 1 week, 1, 3 and 6 months after surgery. 4. Macular thickness is measured using the Cirrus-HD OCT (macular cube 512x128) pre-operatively, 1 week, 1, 3 and 6 months after surgery 5. Optic nerve retinal nerve fiber layer (RNFL) and morphologic parameters are measured using the Cirrus-HD OCT (optic disc cube 200x200) pre-operatively, 1 week, 1, 3 and 6 months after surgery	—

Measure

Time frame

1. Phacoemulsification is assessed using the inifinity phacoemulsification machine at the end of surgery at the surgical visit. 2. Endothelial cell quantitative and morphologic analysis is measured using a SP-3000 specular microscope pre-operatively, 1 day, 1 week, 1, 3 and 6 months after surgery 3. IOL position is assessed by measuring the torizontal tilt using a TMS-5 Scheimpflug Topographer 1 day, 1 week, 1, 3 and 6 months after surgery and IOL decentration using Adobe Photoshop 1 week, 1, 3 and 6 months after surgery. 4. Macular thickness is measured using the Cirrus-HD OCT (macular cube 512x128) pre-operatively, 1 week, 1, 3 and 6 months after surgery 5. Optic nerve retinal nerve fiber layer (RNFL) and morphologic parameters are measured using the Cirrus-HD OCT (optic disc cube 200x200) pre-operatively, 1 week, 1, 3 and 6 months after surgery

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Countries

Spain

Outcome results

None listed

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