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.
Sponsor:
Information provided by (Responsible Party):
Abhay R. Vasavada, Iladevi Cataract and IOL Research Center
ClinicalTrials.gov Identifier:
NCT01818037
First received: March 21, 2013
Last updated: March 25, 2013
Last verified: March 2013
  Purpose

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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Posterior synechiae [ Time Frame: 45 months postoperatively ] [ Designated as safety issue: Yes ]
  • visual axis obscuration [ Time Frame: 45 months ] [ Designated as safety issue: No ]
  • axial length rate of growth [ Time Frame: 45 months postoperatively ] [ Designated as safety issue: No ]
  • central corneal thickness [ Time Frame: 45 months postoperatively ] [ Designated as safety issue: No ]
  • visual acuity [ Time Frame: 45 months postoperatively ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   1 Month to 24 Months
Genders Eligible for Study:   Both
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.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01818037

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

No publications provided

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

Additional relevant MeSH terms:
Cataract
Microphthalmos
Lens Diseases
Eye Diseases
Eye Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 28, 2014