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

NCT01818037 | Completed DMC

• 1 other identifier: 13-002
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Microphthalmos With Congenital Cataracts

Outcome Measures

Primary Outcomes (1)

• Glaucoma following cataract surgery

  45 months postoperative

Secondary Outcomes (5)

• Posterior synechiae

  45 months postoperatively

• visual axis obscuration

  45 months

• axial length rate of growth

  45 months postoperatively

• central corneal thickness

  45 months postoperatively

• visual acuity

  45 months postoperatively

Study Arms (1)

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

Interventions

Cataract surgery PROCEDURE

Microphthalmos with congenital cataract

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Iladevi Cataract and IOL Research Center: lead

Study Sites (1)

Iladevi Cataract & IOL Research Center

Ahmedabad, Gujarat, 380052, India

Location

MeSH Terms

Interventions

Cataract Extraction

Intervention Hierarchy (Ancestors)

Refractive Surgical Procedures; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Iladevi Cataract and IOL Research Center

Study Record Dates

• First Submitted: March 21, 2013
• First Posted: March 26, 2013
• Study Start: January 1, 2003
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: March 26, 2013

Record last verified: 2013-03

Locations

IN (1)