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

• Sponsor: Iladevi Cataract and IOL Research Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01818037
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Duration (Months): 122
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Microphthalmos With Congenital Cataracts	Procedure: Cataract surgery

Study Design

• Study Type: Observational
• Actual Enrollment: 36 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: A Long-term Postoperative Outcome After Bilateral Congenital Cataract Surgery in Eyes With Microphthalmos
• Study Start Date: Jan 1, 2003
• Actual Primary Completion Date: Mar 1, 2013
• Actual Study Completion Date: Mar 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Microphthalmos with congenital cataract 72 eyes of 36 patients with microphthalmos who underwent bilateral congenital cataract surgery between January 2003 and June 2008.	Procedure: Cataract surgery

Outcome Measures

Primary Outcome Measures

1. Glaucoma following cataract surgery [45 months postoperative]

Secondary Outcome Measures

1. Posterior synechiae [45 months postoperatively]

2. visual axis obscuration [45 months]

3. axial length rate of growth [45 months postoperatively]

4. central corneal thickness [45 months postoperatively]

5. visual acuity [45 months postoperatively]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Month to 24 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Iladevi Cataract & IOL Research Center	Ahmedabad	Gujarat	India	380052

Sponsors and Collaborators

• Iladevi Cataract and IOL Research Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Abhay R. Vasavada, Director, Iladevi Cataract and IOL Research Center, Iladevi Cataract and IOL Research Center
• ClinicalTrials.gov Identifier: NCT01818037
• Other Study ID Numbers: 13-002
• First Posted: Mar 26, 2013
• Last Update Posted: Mar 26, 2013
• Last Verified: Mar 1, 2013

• Additional relevant MeSH terms: Cataract; Microphthalmos

Study Results

No Results Posted as of Mar 26, 2013