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

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ClinicalTrials.gov Identifier: NCT01818037
Recruitment Status : Completed
First Posted : March 26, 2013
Last Update Posted : March 26, 2013
Sponsor:
Information provided by (Responsible Party):
Abhay R. Vasavada, Iladevi Cataract and IOL Research Center

March 21, 2013
March 26, 2013
March 26, 2013
January 2003
March 2013   (Final data collection date for primary outcome measure)
Glaucoma following cataract surgery [ Time Frame: 45 months postoperative ]
Same as current
No Changes Posted
  • Posterior synechiae [ Time Frame: 45 months postoperatively ]
  • visual axis obscuration [ Time Frame: 45 months ]
  • axial length rate of growth [ Time Frame: 45 months postoperatively ]
  • central corneal thickness [ Time Frame: 45 months postoperatively ]
  • visual acuity [ Time Frame: 45 months postoperatively ]
Same as current
Not Provided
Not Provided
 
Long-term Postoperative Outcomes After Bilateral Congenital Cataract Surgery in Eyes With Microphthalmos
A Long-term Postoperative Outcome After Bilateral Congenital Cataract Surgery in Eyes With Microphthalmos

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
72 eyes of 36 patients with microphthalmos who underwent bilateral congenital cataract surgery between January 2003 and June 2008.
Microphthalmos With Congenital Cataracts
Procedure: Cataract surgery
Microphthalmos with congenital cataract
72 eyes of 36 patients with microphthalmos who underwent bilateral congenital cataract surgery between January 2003 and June 2008.
Intervention: Procedure: Cataract surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
Same as current
March 2013
March 2013   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
1 Month to 24 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT01818037
13-002
Yes
Not Provided
Not Provided
Abhay R. Vasavada, Iladevi Cataract and IOL Research Center
Iladevi Cataract and IOL Research Center
Not Provided
Not Provided
Iladevi Cataract and IOL Research Center
March 2013