Primary Objective: Comparison of incidence of post-cataract extraction ocular inflammation with subconjunctival steroid injection versus traditional eye drops.Secondary Objective: Evaluation of usefulness of physostigmine following cataract surgery…
ID
Source
Brief title
Condition
- Ocular infections, irritations and inflammations
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Laser flarecount, examined by laser flarecounter, before operation and on day
21.
Thickness of the macula, examined by OCT, before operation and on day 21.
Secondary outcome
Intraocular pressure on day 1 and 21.
Phaco time and energy.
Number of extra visits due to complaints of post-op irritation.
Number of extra visits due to complaints of reduced visual acuity.
Pain (scaling 1-10) on day 1.
Incidence of anterior synechiae on day 21.
BCVA on day 21.
Background summary
Cataract extraction is the most frequently performed surgical intervention. A
relatively high prevalence of post-op ocular inflammation, needing additional
treatment and visits, has prompted the search for a treatment to replace the
traditionally prescribed topical steroids. An subconjunctival steroid depot
appears to be the most promising alternative.
The use of miotics after cataract extraction appears to have lost its
rationale. Therefore, the efficacy of Eserine will be evaluated.
Study objective
Primary Objective: Comparison of incidence of post-cataract extraction ocular
inflammation with subconjunctival steroid injection versus traditional eye
drops.
Secondary Objective: Evaluation of usefulness of physostigmine following
cataract surgery.
Study design
Randomized.
Group 1 (n=100): subconjunctival depot of betamethasone.
Group 2 (n=100): treatment with traditional dexamethasone eye drops.
Group 3 (n=100): as group 2 plus administration of Eserine.
Group 4 (n=100): as group 1 plus administration of Eserine.
Intervention
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.
Study burden and risks
In order to reduce the risk of anterior uveitis or macular edema, post-op
steroids are prescribed. Administration of a single intraoperative injection of
betamethasone hardly involves any additional risk, but is expected to reduce
the patient*s post-op inconvenience and to increase the efficacy of medication.
In order to reduce the risk of dislocation of the implanted lens, eserine is
(still) applied. This can result in temporarily increased irritation of the eye
or pain around the eye. Should this study demonstrate that eserine does not
reduce the risk of lens dislocation then the use of this medication can be
suspended indefinitely.
Schiedamse Vest 180
3011 BH Rotterdam
NL
Schiedamse Vest 180
3011 BH Rotterdam
NL
Listed location countries
Age
Inclusion criteria
Cataract extraction indication.
Age > 18 years.
Caucasian.
Informed consent.
Post-op follow-up must be feasible.
Exclusion criteria
Subcapsular posterior cataract (very soft, short phaco time).
Brunescens or mature cataract (hard, long phaco time).
Diabetes mellitus.
Age-related macula degeneration.
History of uveitis.
Glaucoma.
History of steroid response.
Per-operative iris manipulation (e.g. miosis or posterior synechiae).
Pre-operative synechiae anterior.
Systemic steroid medication.
Chemotherapy.
Peroperative contact with vitreous.
Sickle cell anemia.
Corneal complications.
Atopy.
HSV.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2006-001486-41-NL |
| CCMO | NL11114.078.06 |