ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	4 March 2019
Main ID:	ISRCTN14007865
Date of registration:	13/03/2017
Prospective Registration:	No
Primary sponsor:	Mediker
Public title:	Comparison of two cataract surgery techniques: conventional phacoemulsification vs femtosecond laser-assisted cataract surgery
Scientific title:	Cataract surgery prospective comparative clinical trial: femtosecond laser assisted cataract surgery vs conventional phacoemulsification
Date of first enrolment:	28/10/2013
Target sample size:	100
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN14007865
Study type:	Interventional
Study design:	Single-centre prospective intra-participant randomised parallel trial (Treatment)
Phase:	Not Applicable

Countries of recruitment
Spain

Contacts

Name:	Javier Mendicute
Address:	Servicio de Oftalmología Hospital Universitario Donostia Paseo del Dr. Beguiristain s/n 20014 San Sebastian Spain
Telephone:
Email:
Affiliation:

Name:
Address:
Telephone:
Email:
Affiliation:

Key inclusion & exclusion 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:
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Cataract
Eye Diseases
Cataract

Intervention(s)

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 the technique not used on their other eye. Randomisation is undertaken using computer randomisation.

Group 1: Eyes that are randomised for conventional phacoemulsification are operated following standard phaco-chop techniques using the Infinity phacoemulsification system.

Group 2: Eyes that are randomised for femtosecond laser-assisted cataract surgery undergo femtosecond laser pretreatment with the Victus Femtosecond Laser Platform and phacoemulsification with the Infinity phacoemulsification system follows.

The same experienced surgeon performs all surgeries. Phacoemulsification parameters, viscoelastic device and monofocal intraocular lens are the same for all eyes. Preoperative sedation and midriasis protocol and postoperative topical treatment are the same in all cases.

Follow up involves visual acuity and quality determination, aswell as endothelial analysis, IOL position assessment and macular and optic nerve evaluation. Postoperative visits are programmed 1 day, 1 week, 1, 3 and 6 months after surgery.

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

883PLP DSS 013-14

Source(s) of Monetary Support

Mediker

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Gipuzcoa Healthcare Area Clinic Investigation Ethics Committee (Comité Ético de Investigación Clínica del Área Sanitaria de Gipuzkoa), 24/09/2013

Results

Results available:	Yes
Date Posted:
Date Completed:	30/01/2015
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.