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Trial record 1 of 4 for:    "Microphthalmos" OR "microphthalmia with linear skin defects syndrome"
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Long-term Postoperative Outcomes After Bilateral Congenital Cataract Surgery in Eyes With Microphthalmos

This study has been completed.
Information provided by (Responsible Party):
Abhay R. Vasavada, Iladevi Cataract and IOL Research Center Identifier:
First received: March 21, 2013
Last updated: March 25, 2013
Last verified: March 2013

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 Intervention
Microphthalmos With Congenital Cataracts
Procedure: Cataract surgery

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Long-term Postoperative Outcome After Bilateral Congenital Cataract Surgery in Eyes With Microphthalmos

Resource links provided by NLM:

Further study details as provided by Iladevi Cataract and IOL Research Center:

Primary Outcome Measures:
  • Glaucoma following cataract surgery [ Time Frame: 45 months postoperative ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 36
Study Start Date: January 2003
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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


Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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.

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Please refer to this study by its identifier: NCT01818037

Iladevi Cataract & IOL Research Center
Ahmedabad, Gujarat, India, 380052
Sponsors and Collaborators
Iladevi Cataract and IOL Research Center
  More Information

Responsible Party: Abhay R. Vasavada, Director, Iladevi Cataract and IOL Research Center, Iladevi Cataract and IOL Research Center Identifier: NCT01818037     History of Changes
Other Study ID Numbers: 13-002
Study First Received: March 21, 2013
Last Updated: March 25, 2013

Additional relevant MeSH terms:
Lens Diseases
Eye Diseases
Eye Abnormalities
Congenital Abnormalities processed this record on May 23, 2017