A Long-term Postoperative Outcome After Bilateral Congenital Cataract Surgery in Eyes With Microphthalmos
Procedure Data
Collected from today forward - ProspectiveCase-Only
Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.Summary
Study start date: January 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.36 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-only
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 1 to 24 Months
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
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.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Iladevi Cataract & IOL Research Center
Ahmedabad, IndiaOpen Iladevi Cataract & IOL Research Center in Google Maps