Subconjunctival steroid depot after cataract extraction
| ISRCTN | ISRCTN41133247 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41133247 |
| Protocol serial number | OZR-2006-01, NL768, NTR779 |
| Sponsor | The Rotterdam Eye Hospital (Oogziekenhuis Rotterdam) (OZR) (The Netherlands) |
| Funder | Stichting Wetenschappelijk Onderzoek het Oogziekenhuis (The Netherlands) |
- Submission date
- 28/12/2006
- Registration date
- 28/12/2006
- Last edited
- 05/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Oogziekenhuis Rotterdam
Schiedamsevest 180
Rotterdam
3011 BH
Netherlands
| Phone | +31(0)10 401 7777 |
|---|---|
| deWaard@oogziekenhuis.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Subconjunctival steroid depot after cataract extraction |
| Study objectives | A single subconjunctival Celestone chronodose injection immediately following cataract extraction reduces the incidence of post-operative ocular inflammation when compared with conventional post-operative eye drops therapy. Post-op administration of eserine does not reduce the incidence of dislocation of the intraocular lens implant any further. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Cataract |
| Intervention | Group 1: subconjunctival steroid injection. Group 2: topical steroids (three times per day during three weeks). Group 3: as group two plus Eserine. Group 4: as group one plus Eserine. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Steroids, Celestone chronodose and Eserine |
| Primary outcome measure(s) |
1. Laser flarecount, examined by laser flarecounter, before operation and on day 21. |
| Key secondary outcome measure(s) |
1. Number of extra visits due to complaints of post-op irritation. |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 400 |
| Total final enrolment | 400 |
| Key inclusion criteria | 1. Cataract extraction indication 2. Aged over 18 years 3. Caucasian - informed consent 4. Post-op follow-up must be feasible |
| Key exclusion criteria | 1. Subcapsular posterior cataract (very soft, short phaco time) 2. Brunescens or mature cataract (hard, long phaco time) 3. Diabetes mellitus 4. Age-related macula degeneration 5. History of uveitis 6. Glaucoma 7. History of steroid response 8. Per-operative iris manipulation (e.g. miosis or posterior synechiae) 9. Pre-operative synechiae anterior 10. Systemic steroid medication 11. Chemotherapy 12. Peroperative contact with vitreous 13. Sickle cell anemia 14. Corneal complications 15. Atopy 16. Herpes Simplex Virus (HSV) |
| Date of first enrolment | 01/01/2007 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
3011 BH
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2012 | 05/01/2021 | Yes | No |
Editorial Notes
05/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The NTR numbers have been added.
