Condition category
Eye Diseases
Date applied
08/12/2017
Date assigned
25/03/2018
Last edited
23/03/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
A cataract is a clouding of the lens in the eye which decreases vision. It is estimated that 25% to 40% of cataract patients have astigmatism, a focusing disorder of the eye that distorts vision. During cataract surgery toric intraocular lenses (IOLs) can be implanted inside the eye to replace the eye's natural lens and correct astigmatism. In the standard procedure, ophthalmic viscosurgical devices (OVD) are solutions used during implantation of IOLs to create and maintain space in the eye. Hydroimplantation is a technique for implantation of a foldable IOL without an OVD. The aim of this study is to compare the OVD and hydroimplantation techniques for the implantation of a toric IOL.

Who can participate?
Patients with cataract and regular astigmatism between 1.0 and 3.0 diopters (D)

What does the study involve?
Participants undergo phacoemulsification (cataract removal) and are randomly allocated to undergo implantation of toric IOLs with either the OVD technique or the hydroimplantation technique. In the OVD group, the toric IOLs are implanted with OVD. In the hydroimplantation group, balanced salt solution (BSS) is used instead of OVD during implantation of toric IOLs. The eyes are examined at 2 hours, 1 day, 1 week, 1 month, and 3 months after surgery.

What are the possible benefits and risks of participating?
The hydroimplantation technique provides similar visual outcomes to the conventional technique using OVDs for the implantation of toric IOLs, but it has the advantage of increased efficiency, reduced surgical time and cost, and does not cause high intraocular pressure. The hydroimplantation technique is also useful for the alignment of the toric IOLs during the surgery. However, this technique is only recommended for experienced surgeons, and may cause complications for novice ophthalmologists.

Where is the study run from?
Jinling Hospital (China)

When is study starting and how long is it expected to run for?
January 2012 to December 2014

Who is funding the study?
Jinling Hospital (China)

Who is the main contact?
Dr Zhenping Huang
hzpjlyy@hotmail.com

Trial website

Contact information

Type

Public

Primary contact

Dr Yueqin Chen

ORCID ID

Contact details

Jinling Hospital
305 East Zhongshan Road
Nanjing
210002
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2016007

Study information

Scientific title

Comparison of two techniques for toric intraocular lens implantation: hydroimplantation versus ophthalmic viscosurgical devices

Acronym

Study hypothesis

In this study, patients with cataract and preexisting regular corneal astigmatism between 1.0 and 3.0 diopters (D) underwent phacoemulcification and implantation of toric IOLs with the ophthalmic viscosurgical device (OVD) technique or hydroimplantation technique.

The aim of this study was to evaluate and compare the clinical results between the OVD group and the hydroimplantation group for the implantation of a single-piece, acrylic foldable toric IOL. In the OVD group, the toric IOLs were implanted with OVD. In the hydroimplantation group, balanced salt solution (BSS) was used instead of OVD during implantation of toric IOLs.

It is hypothesized that the hydroimplantation technique will provides comparable visual outcomes to the OVD technique for the implantation of toric IOLs but with increased efficiency, reduced surgical time and cost, and no concerns of OVD-induced elevated IOP.

Ethics approval

Ethical Committee of Jinling Hospital, 25/08/2011, ref: 2011NLY-027

Study design

Prospective interventional single-center study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Eyes with cataract and preexisting regular corneal astigmatism between 1.0 and 3.0 diopters (D)

Intervention

60 eyes with cataract and preexisting regular corneal astigmatism underwent phacoemulsification and AcrySof toric IOLs implantation, and the eyes were randomized to undergo either the OVD technique or the hydroimplantation technique.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measure

1. Postoperative IOP is measured using the Computerized Tonometer at 2 hours, 1 day, 1 week, 1 month, and 3 months after surgery
2. Postoperative UDVA is measured using Snellen or “E” chart 3 months after surgery
3. ECD is measured using SP-3000P, Topcon Corp. Tokyo, Japan at 3 months after surgery
4. Refractive astigmatism is measured using keratometry: IOLMaster at 3 months after surgery
5. IOL rotation is measured using a slit lamp at 3 months after surgery
6. Time taken for IOL implantation is measured using records at time of surgery

Secondary outcome measures

Astigmatism vector analysis is measured using Thibos and Horner’s power vector notation at 3 months after surgery

Overall trial start date

01/01/2012

Overall trial end date

31/12/2014

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Age-related cataract with preoperative corneal astigmatism between 1.0 and 3.0 D and nucleus sclerosis up to grade 3
2. 40-90 years old

Participant type

Patient

Age group

Mixed

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. Patients with history of previous ocular surgery
2. Pupil size less than 7.5 mm after dilatation
3. Anterior chamber less than 2.25 mm
4. Compromised endothelial cell functio
5. Corneal disorder
6. Complicated cataract
7. Glaucoma
8. Pseudoexfoliation
9. Severe myopia
10. Diabetic retinopathy

Recruitment start date

10/01/2012

Recruitment end date

29/05/2014

Locations

Countries of recruitment

China

Trial participating centre

Jinling Hospital
305 East Zhongshan Road
Nanjing
210002
China

Sponsor information

Organisation

Jinling Hospital

Sponsor details

305 East Zhongshan Road
Nanjing
210002
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Jinling Hospital

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The manuscript is under minor revision with BMC Ophthalmology.

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Yueqin Chen.

Intention to publish date

23/06/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes