Long-term Postoperative Outcomes After Bilateral Congenital Cataract Surgery in Eyes With Microphthalmos

NCT ID: NCT01818037

Last Updated: 2013-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2003-01-31

Study Completion Date

2013-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Microphthalmos With Congenital Cataracts

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Microphthalmos with congenital cataract

72 eyes of 36 patients with microphthalmos who underwent bilateral congenital cataract surgery between January 2003 and June 2008.

Cataract surgery

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cataract surgery

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Iladevi Cataract and IOL Research Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Abhay R. Vasavada

Director, Iladevi Cataract and IOL Research Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Iladevi Cataract & IOL Research Center

Ahmedabad, Gujarat, India

Site Status

Countries

Review the countries where the study has at least one active or historical site.

India

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

13-002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.