Subconjunctival steroid depot after cataract extraction.

Effects of post-operative topical steroid versus intraoperative subconjunctival steroid injection and postoperative miotic on intraocular inflammation following cataract extraction.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24307

Enrollment

400

Registered

2006-09-25

Start date

2007-01-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cataract.

Interventions

Group 1: subconjunctival steroid injection. Group 2: topical steroids (3x per day during 3 weeks). Group 3: as group 2 plus Eserine. Group 4: as group 1 plus Eserine.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Cataract extraction indication. 2. Age > 18 years. 3. Caucasian.- Informed consent. 4. Post-op follow-up must be feasible.

Exclusion criteria

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. HSV.

Design outcomes

Primary

Measure	Time frame
1. Laser flarecount, examined by laser flarecounter, before operation and on day 21 . 2. Thickness of the macula, examined by OCT, before operation and on day 21.	—

Secondary

Measure	Time frame
1. Number of extra visits due to complaints of post-op irritation. 2. Number of patients with macular edema, examined by OCT, on day 21. 3. Intraocular pressure on day 1 and 21. 4. Number of extra visits due to complaints of reduced visual acuity (miotic wearing off). 5. Pain (scaling 1-10) on day 1. 6. Incidence of anterior synechiae (gonioscopic evaluation) on day 21. 7. BCVA using the ETDRS chart on day 21.	—

Measure

Time frame

1. Number of extra visits due to complaints of post-op irritation. 2. Number of patients with macular edema, examined by OCT, on day 21. 3. Intraocular pressure on day 1 and 21. 4. Number of extra visits due to complaints of reduced visual acuity (miotic wearing off). 5. Pain (scaling 1-10) on day 1. 6. Incidence of anterior synechiae (gonioscopic evaluation) on day 21. 7. BCVA using the ETDRS chart on day 21.

—

Contacts

Public ContactP.W.T. Waard, de

Oogziekenhuis Rotterdam Schiedamsevest 180

deWaard@oogziekenhuis.nl+31(0)10 4017777

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)