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

ISRCTN ISRCTN55696872
DOI https://doi.org/10.1186/ISRCTN55696872
Secondary identifying numbers 2016007
Submission date
08/12/2017
Registration date
25/03/2018
Last edited
23/11/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Dr Yueqin Chen
Public

Jinling Hospital
305 East Zhongshan Road
Nanjing
210002
China

Study information

Study designProspective interventional single-center study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet No participant information sheet available
Scientific titleComparison of two techniques for toric intraocular lens implantation: hydroimplantation versus ophthalmic viscosurgical devices
Study objectivesIn 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(s)Ethical Committee of Jinling Hospital, 25/08/2011, ref: 2011NLY-027
Health condition(s) or problem(s) studiedEyes with cataract and preexisting regular corneal astigmatism between 1.0 and 3.0 diopters (D)
Intervention60 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 typeProcedure/Surgery
Primary outcome measure1. 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 measuresAstigmatism vector analysis is measured using Thibos and Horner’s power vector notation at 3 months after surgery
Overall study start date01/01/2012
Completion date31/12/2014

Eligibility

Participant type(s)Patient
Age groupMixed
SexBoth
Target number of participants60
Total final enrolment60
Key inclusion criteria1. 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
Key exclusion criteria1. 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
Date of first enrolment10/01/2012
Date of final enrolment29/05/2014

Locations

Countries of recruitment

  • China

Study participating centre

Jinling Hospital
305 East Zhongshan Road
Nanjing
210002
China

Sponsor information

Jinling Hospital
Hospital/treatment centre

305 East Zhongshan Road
Nanjing
210002
China

ROR logo "ROR" https://ror.org/04kmpyd03

Funders

Funder type

Hospital/treatment centre

Jinling Hospital

No information available

Results and Publications

Intention to publish date23/06/2018
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planThe manuscript is under minor revision with BMC Ophthalmology.
IPD sharing planThe datasets generated during and/or analysed during the current study are/will be available upon request from Dr Yueqin Chen.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 24/04/2018 23/11/2020 Yes No

Editorial Notes

23/11/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.