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
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
Public
Jinling Hospital
305 East Zhongshan Road
Nanjing
210002
China
Study information
| Study design | Prospective interventional single-center study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Comparison of two techniques for toric intraocular lens implantation: hydroimplantation versus ophthalmic viscosurgical devices |
| Study objectives | 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(s) | Ethical Committee of Jinling Hospital, 25/08/2011, ref: 2011NLY-027 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/01/2012 |
| Completion date | 31/12/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 60 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/01/2012 |
| Date of final enrolment | 29/05/2014 |
Locations
Countries of recruitment
- China
Study participating centre
Nanjing
210002
China
Sponsor information
Hospital/treatment centre
305 East Zhongshan Road
Nanjing
210002
China
"ROR" |
https://ror.org/04kmpyd03 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 23/06/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The manuscript is under minor revision with BMC Ophthalmology. |
| IPD sharing plan | The 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.
