Microphthalmos With Congenital Cataracts Clinical Trial
Official title:
A Long-term Postoperative Outcome After Bilateral Congenital Cataract Surgery in Eyes With Microphthalmos
| Verified date | March 2013 |
| Source | Iladevi Cataract and IOL Research Center |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | India: Data Monitoring Committee |
| Study type | Observational |
Cataract surgery in infantile eyes, which are microphthalmic, can be even more demanding.
In addition, the frequent presence of other ocular and systemic anomalies such as nystagmus,
glaucoma, amblyopia, and higher rate of postoperative complications may limit the success of
cataract surgery.
In our previous study, the investigators examined the intraoperative performance and
postoperative outcomes of bilateral cataract surgery in microphthalmic eyes of patients
before their first birthday. At 1 year, the postoperative results showed that good visual
outcomes could be obtained in microphthalmic eyes.
Since only a few studies have reported outcomes, and that too only short term of cataract
surgery on microphthalmic eyes, in this prospective observational study we evaluated the
long-term impact of bilateral cataract surgery on eyes with microphthalmos. The
investigators examined the outcomes, complication rates, influence of age at surgery on
pattern of axial growth and central corneal thickness and visual and orthoptic assessment in
these eyes.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | March 2013 |
| Est. primary completion date | March 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 1 Month to 24 Months |
| Eligibility |
Inclusion Criteria: - Presence of microphthalmos and congenital cataract. - Microphthalmos was defined as an eye with an axial length (AL) that is more than 2 SD smaller than the normal for that age group according to Gordon and Donzes Exclusion Criteria: - Children with congenital anomalies such as posterior persistent fetal vasculature causing stretching of the ciliary processes or a tractional retinal detachment, aniridia, and chorioretinal coloboma were excluded. |
Observational Model: Case-Only, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| India | Iladevi Cataract & IOL Research Center | Ahmedabad | Gujarat |
| Lead Sponsor | Collaborator |
|---|---|
| Iladevi Cataract and IOL Research Center |
India,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Glaucoma following cataract surgery | 45 months postoperative | Yes | |
| Secondary | Posterior synechiae | 45 months postoperatively | Yes | |
| Secondary | visual axis obscuration | 45 months | No | |
| Secondary | axial length rate of growth | 45 months postoperatively | No | |
| Secondary | central corneal thickness | 45 months postoperatively | No | |
| Secondary | visual acuity | 45 months postoperatively | No |